The overall purpose of this study is to characterise the clinical safety and performance of the AB1 instrument in patients with pathologically confirmed malignancy eligible for surgical resection of their nodule, receiving bronchoscopic ablation…
ID
Source
Brief title
Condition
- Respiratory and mediastinal neoplasms malignant and unspecified
- Respiratory tract neoplasms
- Respiratory tract therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety objectives are as follows: Stage A - Ablate (Day 0) & Resect
(Day 0) To assess and characterize any serious device-related intra-procedural
adverse events associated with the delivery of microwave energy by the AB1
system in subjects undergoing bronchoscopic pulmonary nodule ablation prior to
the first surgical incision for the resection. Stage B - Ablate (Day 0) &
Resect (Resection Day 7-21) To assess and characterize any serious
device-related adverse events associated with the delivery of microwave energy
by the AB1 system in subjects undergoing bronchoscopic pulmonary nodule
ablation (prior to the first surgical incision for the resection), in subjects
who will undergo surgical resection. The primary performance (efficacy)
objective is: To evaluate the ability of the AB1 instrument to
bronchoscopically be positioned in the targeted lung tissue confirmed by
fluoroscopy, CBCT or direct bronchoscopic vision and deliver scheduled
microwave energy to the targeted tissue. The primary safety endpoint/outcome
measures are as follows: Stage A - Ablate (Day 0) & Resect (Day 0)
Identification of serious device-related intra-procedural adverse events
related to the use of the AB1 system on Day 0 prior to surgical resection
defined by the initial skin incision (number and nature of serious adverse
events, both device- and procedure related, will be identified). Stage B -
Ablate (Day 0) & Resect (Resection Day 7-21) Identification of serious
device-related adverse events related to the use of the AB1 system from day 0
up to initiation of surgical resection procedure (number and nature of serious
adverse events, both device- and procedure related, will be identified). The
primary performance endpoint/outcome is: Initial technical success, defined as
successful bronchoscopic access by the AB1 instrument of the target tissue,
delivery of scheduled microwave energy to the target tissue (per pre-specified
target) and confirmed ablation as evidenced by macroscopic assessment
post-surgical resection of the ablated lesion.
Secondary outcome
Secondary performance objectives:
To correlate the volumes and dimensions of thermally affected tissue provided
in Creo Medical AB1 instrument instructions for use (obtained in ex vivo
porcine lung tissue) with the dimensions and volumes measured in lung nodules
using the AB1 System to deliver microwave energy for the same period, during
the proposed clinical study.
To evaluate the ease of use of the AB1 System, including physician assessments
of set-up, treatment selection, advancement and withdrawal of the AB1
Instrument from the bronchoscope, and electrosurgical system clean up, and
instrument disposal.
Secondary performance endpoints/outcome measures:
1. Assessment/visualization/quantification of the dimensions of the ablated
tissue including assessment of margin relative to lesion.*
2. Assessment/visualization/quantification of the dimensions of the ablation
observed within the post-ablation CT.
3. Procedural Time
4. Assessment of ease of system use, including:
a. Clarity of instructions as reported by clinicians on a Likert scale of 1 to
7, with 1 being *extremely clear* and 7 being *extremely difficult to follow*.
b. Ease of set up as reported by clinicians on a Likert scale of 1 to 7, with 1
being *extremely easy* and 7 being *extremely difficult.*
c. Ease of selection of instrument from drop-down menu as reported by
clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7
being *extremely difficult.*
d. Ease of selecting treatment (power delivery time) using the diagrams and
figures provided in the IFU, as reported by clinicians on a Likert scale of 1
to 7, with 1 being *extremely easy* and 7 being *extremely difficult.*
e. Ease of footswitch use to control energy delivery as reported by clinicians
on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being
*extremely difficult.*
f. Ease of advancing AB1 instrument through bronchoscope to target tissue as
reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely
easy* and 7 being *extremely difficult.*
g. Ease of withdrawing AB1 instrument from bronchoscope as reported by
clinicians on a Likert scale of 1 to 7, with 1 being *extremely easy* and 7
being *extremely difficult.*
h. Ability to visualize the AB1 antenna using CT as reported by clinicians on a
Likert scale of 1 to 7, with 1 being *extremely easy* and 7 being *extremely
difficult.*
i. Ease of ability to maintain a sterile field using the Sterile Sheaths as
reported by clinicians on a Likert scale of 1 to 7, with 1 being *extremely
easy* and 7 being *extremely difficult.*
j. Ease of disposal of contaminated instruments and accessory interface cable
and sterile sheaths, as reported by clinicians on a Likert scale of 1 to 7,
with 1 being *extremely easy* and 7 being *extremely difficult.*
Background summary
Lung cancer is the leading cause of cancer death in the world. Due to the lack
of symptoms, it is not uncommon for lung cancer to present in late stages
contributing to its high mortality. Lung cancer accounts for 20% of all cancers
in men, with a lifetime risk of 1 in 13 men, and accounts for 12% of all
cancers in women with a lifetime risk of 1 in 23 women. Worldwide, lung cancer
incidence is estimated at 1.6 million, with approximately 1,095,200 cases in
males and 513,600 in females. In 2008 there were 724,300 new diagnoses in the
developed world and 884,500 new patients diagnosed with lung cancer in the
developing world. The global burden of lung cancer has increased dramatically
in recent years, reflecting the smoking epidemic that continues to affect the
developing world. In addition to primary cancer being common, the lungs are
also a frequent site for early metastases from renal, colon, and breast
cancers.
The lung has 24 generations in the typical person. A standard bronchoscope can
visualize and directly sample lesions within these proximal generations.
Outside of this range, several tools, including ultra-thin bronchoscopes,
radial probe endobronchial ultrasound (rEBUS), electromagnetic navigation
(EMN), Cone Beam Computed Tomography (CBCT) assisted bronchoscopy can assist in
the diagnosis of peripheral disease. After the diagnosis, bronchoscopic staging
is completed using the endobronchial ultrasound guided transbronchial needle
aspiration (EBUS-TBNA) bronchoscope. The diagnosis, its location, and the stage
will dictate therapeutic options.
Surgery remains the gold standard treatment for patients with early-stage
resectable disease who are operatively fit, while stereotactic body
radiotherapy (SBRT) is the most common therapy offered for those patients that
decline surgery or who have an unacceptable perioperative risk profile.
Clinical equipoise between surgery and SBRT is purported, however, significant
methodological challenges were met during each of the two primary studies
investigating this relationship, with further randomized data needed. Patients
undergoing interventional therapy for lung cancer are frequently co-morbid,
with substantial post-operative morbidly recognized. SBRT delivers precise,
very intense doses of radiation, with self-limiting fatigue very common, while
pneumonitis, dyspnoea, chest pain, and pneumonia are recognized to occur in 2.7
- 27%. Furthermore, and, while rates of clinically significant lung toxicity
following SABR are low, there is growing evidence that subpopulations of
patients (i.e. with underlying lung fibrosis) are at increased risk. Finally,
chest wall toxicity from SABR may include rib fractures or pain. Chest wall
pain is reported in approximately 10% of patients, with grade 3 toxicity in
about 2.0% and a median time to onset of >= 6 months following treatment.
Computer tomography (CT) guided microwave ablation, radiofrequency ablation and
cryoablation are alternative treatments for small lung lesions but necessitates
a needle being passed through the lung, to effect percutaneous ablation. An
intrinsic risk of pneumothorax and haemorrhage is therefore associated with
percutaneous access of lung lesions.
Targeted ablation with an endobronchial microwave instrument such as Creo
Medical*s AB1 instrument offers the potential for focal treatment, whilst
potentially avoiding the risks and morbidity associated with surgery,
percutaneous ablation, or SBRT. When utilized in conjunction with an
endobronchial navigation platform and/or cone beam CT, an ablation instrument
can be reliably manoeuvred to target traditionally difficult-to-access lesions
in the middle and peripheral thirds of the lung. This study investigates
whether microwave energy can be safely delivered to the lung nodules,
facilitating the effective ablation of a target lesion, while relatively
preserving the surrounding parenchymal tissues and avoiding the risks
associated with percutaneous access.
Study objective
The overall purpose of this study is to characterise the clinical safety and
performance of the AB1 instrument in patients with pathologically confirmed
malignancy eligible for surgical resection of their nodule, receiving
bronchoscopic ablation prior to surgery.
Study design
Post-market, prospective, single-arm, multicentre, open-label, non-randomized
study.*The study consists of two (2) sequential stages (Stage A and Stage
B).*Stage A consists of the ablation and the surgical resection being performed
concurrently on Day 0 within a single procedure.*Stage B consists of the
ablation and the surgical resection being performed in separate procedures.*In
Stage B the surgical resection will occur between Day 7 and Day 21,
post-ablation, inclusive of those days. The aim is to follow local guidelines
for treatment of lung cancer. Transition from Stage A to Stage B may begin when
the below criteria are met:
• 15 patients enrolled and treated within either Stage A of this study (CIP ID:
PD-GTD-AB1-003) and/or from the AB1MALT study (CIP ID: 8-AB1-950). NOTE - a
minimum of 3 patients must be treated in Stage A of this study. .
• It should be noted that no investigative site will transition from Stage A to
Stage B if any of the following have occurred:
• In case of 1 death that can be related to the ablation procedure/device, OR
• In case of 1 of the following events:
• Severe complication related to the ablation/device occurs that lead to
cancellation of the resection directly after ablation.
• Severe haemorrhage (definition of severe haemorrhage = bleeding lasting
longer than 30 minutes after all potential interventions that could
solve the bleeding have been employed (Cold NaCL, vasoconstrictors,
intravenous drugs, bronchus blockers) or surgical intervention is
needed to treat the bleeding.
• The occurrence of the above ablation/device related events will trigger
a full review (meeting) of the DMC, at which time the DMC may make a
recommendation to terminate, suspend, or amend the trial or trial protocol, as
appropriate.
- Note: transition from Stage A to Stage B is not mandatory and patients may
continue to be enrolled in the study up to the maximum enrolment target for
concurrent Ablate and resect (Day 0) procedures.
- Note: At any point within the study (even if one (1) or more patients have
been enrolled for Stage B), patients may still be enrolled for concurrent
Ablate and Resect (Day 0) procedure (Stage A) if they elect not to enrol for a
Stage B procedure.
Patients undergoing Stage A will be released from the study at point of
standard of care discharge from hospital post-surgery and will not be followed
as part of the study (patients will receive SoC follow-up and care post release
from study).
Patients undergoing Stage B will have evaluations at follow-up visits conducted
at 7 to 10 days (via phone call) post ablation and prior to the surgical
resection procedure. Stage B patients will be released from the study at point
of standard of care discharge from hospital post-surgery and will not be
followed as part of the study (patients will receive SoC follow-up and care
post release from study).
Intervention
The subject device, the AB1 electrosurgical system is CE Marked for soft tissue
ablation. The device has not been modified and is being used in accordance with
its intended purpose.
The MicroBlate Flex (AB1) System delivers focused microwaves to soft tissue and
can be used to treat cancerous and non-cancerous lung nodules. The AB1
instrument is advanced through a long flexible camera called a bronchoscope,
that has first been passed via the mouth and into the lungs, whilst the subject
is under general anaesthetic.
Participation in this study will include a screening visit, a pre-procedural
assessment, a bronchoscopy procedure that includes MicroBlate Flex treatment,
followed by surgical removal of the treated lesion. A post-procedural
assessment will be made, and follow-up care will be in accordance with the
routine practice of the participant's Doctor and Hospital.
Study burden and risks
Potential risks of study participation are:
· Delay to surgical procedure
· Radiation exposure from study-related CTs
· Injury to bronchi causing bleeding or perforation
· Pulmonary Infections
· Damage to non-target lung tissue
· Risks associated with bronchoscopy (common side effects: wheezing, cough,
sore throat, hoarseness, tension in the throat)
· Risks associated with general anaesthesia
Potential serious adverse events, adverse events, or adverse devices effects
include the following:
• Pneumothorax
• Hemothorax
• Infection/toxicity/pyrogenicity
• Pneumomediastinum (air in the chest between the lungs)
• Fistula
• Air embolism
• Arrhythmia/Ventricular fibrillation
• Bleeding requiring treatment or resulting in prolonged hospitalization
• Hypoxia
• Pleural effusion (water around the lungs)
The participant may receive no personal benefit from the proposed AB1 ablation
treatment.
Potential benefits of study participation include:
• Contribution to the base of knowledge addressing microwave ablation of lung
tissue, which could result in improvements to instruments and
procedures used to treat lung cancer in the future, resulting in
improved healthcare and quality of life for people with lung cancer.
• The ability to reach the periphery of the lung endoluminally may also provide
a reduced complication rate relative to percutaneous ablation
approaches.
This study is being conducted to assess the safety and performance/efficacy of
the intervention and to extend our knowledge about use of the Creo MicroBlate
electrosurgical system and the bronchoscopic approach to assessing and ablating
lung lesions. Endobronchial ablation may prevent or minimize the need for
invasive surgery to treat lung lesions and lead to shorter patient recovery
times, a reduced incidence of complications, decreased hospital stays, and
improved quality of life for lung cancer patients.
Creo House, Beaufort Park, Beaufort Park Way Unit 2
Chepstow NP16 5UH
NL
Creo House, Beaufort Park, Beaufort Park Way Unit 2
Chepstow NP16 5UH
NL
Listed location countries
Age
Inclusion criteria
Patients who: 1. Have signed informed consent. 2. Subject is willing and able
to comply with all aspects of the treatment and evaluation schedule. 3. Are >=
18 years old. 4. Have lung lesion(s)/nodule(s) which are histopathologically
confirmed as cancer. 5. Have soft tissue lung lesion(s): • <= 30 mm in the
largest dimension of the pulmonary window for Stage A • <= 20 mm in the largest
dimension of the pulmonary window for Stage B 6. Are candidates for surgical
resection as determined by a multi-disciplinary team (MDT) or tumour board. 7.
> 10 mm of tumour-free lung parenchyma between target tumour and pleura or
fissure. 8. Subject is willing and able to comply with the study protocol
requirements. 9. Are assigned an ASA (American Society of Anaesthesiologists)
score of <= 3 or the patient is deemed fit for general anaesthesia.
Exclusion criteria
Patients who: 1. Have target nodule(s) within the International Association for
the Study of Lung Cancer (IASLC) *Central Zone* (including bronchial tree,
major vessels, heart, oesophagus, spinal cord, and phrenic & laryngeal nerves).
2. Are pregnant or breast feeding, as determined by standard site practices. 3.
Have participated in an investigational drug or device research study within 30
days of enrolment that would interfere with this study. 4. Have a physical or
psychological condition that would impair study participation or jeopardise the
safety or welfare of the subject. 5. Have an expected survival less than 12
months. 6. Have bleeding diathesis, uncorrectable coagulopathy, or platelet
count <= 100 x 10* /L. 7. Have an implantable device, including pacemakers or
other electronic implants. 8. Have known pulmonary hypertension (PASP
[pulmonary artery systolic pressure] >50mmHg). 9. Who are currently prescribed
anticoagulants, clopidogrel or other platelet aggregation inhibitors which
can*t be stopped or temporarily withheld. 10. Subject had a prior
pneumonectomy. 11. Diagnosis of Small Cell Lung Cancer. 12. Any patient with
clinically significant interstitial lung disease in the zone of planned
ablation. 13. Subject had a therapeutic intervention (e.g., SBRT) within same
lobe as the target lesion. 14. Subjects currently undergoing or underwent
chemotherapy, systemic immunosuppressive treatment, or radiotherapy within 3
months of planned Study procedure.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCTnumber-tobeassigned |
| CCMO | NL83638.018.23 |