This study will evaluate the efficacy of the CbFAS with the optimal safe dose on the conversion of Barrett's epithelium to healthy squamous cell epithelium in a larger cohort. Furthermore, the device performance of the improved CbFAS will be…
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) Efficacy of the CbFAS, defined as the percentage of the (group of) islands
with full conversion from Barrett's epithelium to squamous cell epithelium.
Secondary outcome
1) Percentage of the (group of) islands with 50% conversion from Barrett's
epithelium to squamous cell epithelium.
2) Device performance of theimproved Cryoballoon Focal Ablation System
3) Occurrence of any adverse events.
Background summary
Barrett's Esophagus (BE) is a premalignant lesion which can lead to esophageal
adenocarcinoma. This particular cancer is one of the most rapidly increasing
and deadliest cancers in the western world. Patients with BE are up to 40 times
more at risk of adenocarcinoma than individuals without BE. Once diagnosed with
BE, a patient enters a life-long surveillance program in which upper endoscopy
with biopsy are performed to survey the progression of the Barrett's tissue to
cancer. For more than 20 years, many technologies have been evaluated for
ablation of BE. Elimination of BE and restoration of squamous esophageal lining
has been demonstrated through ablation; however, no ablation technology
currently provides the necessary attributes for wide-spread adoption. The
CryoBalloon Ablation System (System) is designed to address many of the
limitations of ablation technologies. The simplicity of the System allows for
many potential benefits to the patient, the physician, and hospital. Some of
the benefits may include a shorter and safer procedure, an easier deployment
minimizing the need for anesthesiology, and smaller inventory requirements and
no capital equipment improving capital resource utilization The System has
undergone acute and chronic animal testing. The testing was conducted to study
the safety, deliverability and performance characteristics of the System. The
studies were conducted for the evaluation of the device in a normal pig
esophagus at dimensions very similar to a human esophagus. General follow-up
time frames were either 4 days or 28 days. Hereafter, a human trial has been
performed with the circumferential balloon-cryoablation system. This too
appeared safe and feasible in the treatment of a human esophagus. In the past
year a study with the Cryoballoon Focal Ablation System was performed, which
evaluated the safety of the CbFAS with several doses, and the device perfomance
status. Safe ablations could be performed with the maximal dose (10 sec). Yet
the device performance was not optimal. Recently, an improved version of the
CbFAS has been developed.
Study objective
This study will evaluate the efficacy of the CbFAS with the optimal safe dose
on the conversion of Barrett's epithelium to healthy squamous cell epithelium
in a larger cohort. Furthermore, the device performance of the improved CbFAS
will be assessed.
Study design
Prospective, multi-center, single-arm and non-randomized.
Intervention
Endoscopic balloon based cryoablation. The System has two main components: the
delivery catheter with balloon probe and a disposable handle containing the
cryogenic fluid. Deployed through the working channel of an endoscope, the
operation of the System is very similar to the deployment of dilatation
balloons. Once deployed, the balloon is simultaneously inflated and cooled with
cryogenic fluid delivered from the handle. In the focal ablation balloon the
cryogenic fluid will only cool a focal area from one hole in the shaft. BE
cells are ablated as the balloon comes into contact with the esophagus for 10
seconds. After ablation, the System is repositioned for additional ablation or
withdrawn.
Study burden and risks
Patients will undergo 2 gastroscopies in this study, which will both be
performed for regular medical reasons anyway. The difference compared to
regular treatment is that during the first endoscopy patients will be treated
with the focal cryoablation system instead of regular focal RFA treatment.
During follow-up endoscopy a biopsy will be taken from the ablated zone and a
thorough inspection of the esophagus will be performed, after which the regular
treatment will be performed as scheduled for regular medical reasons. This
extra biopsy and inspection will prolong the enoscopy by 5 -10 minutes.
Patients need to adhere to a soft diet during 2 days after the cryoablation
(unless the esophagectomy will follow directly upon the endoscopic treatment).
Furthermore patients will be contacted by telephone 2 days after the
cryoablation.
303 Convention Way Suite 1
Redwood City CA 94063
US
303 Convention Way Suite 1
Redwood City CA 94063
US
Listed location countries
Age
Inclusion criteria
a) Patients with known Barrett*s esophagus, scheduled for treatment with focal radiofrequency ablation (HALO-90) [i.e. in patients with islands or residual Barrett*s after circumferential radiofrequency ablation (HALO-360) or in patients for whom circumferential radiofrequency ablation is not feasible], during which the cryoablation may be performed.
b) Patient is 18 to 80 years of age at the time of consent (inclusive).
c) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution*s reviewing IRB/EC.
d) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
e) Patient is deemed operable per standard institutional criteria.
f) Each patient will have one (group of) island of BE *1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion.
g) BE lesion within the treatment zone should be flat.
Exclusion criteria
a) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
b) Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
c) Patient refuses or is unable to provide written informed consent.
d) Patients that are pregnant.
e) Patient with endoscopically active inflammation in the treatment zone.
f) Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
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 |
|---|---|
| CCMO | NL47404.018.13 |