The objective of this study is to determine the safety and efficacy of the dose required for eradication of LGD or HGD in BE, or residual BE after endoscopic removal of early cancer (*therapeutic dose*), using the C2 CryoBalloon Swipe System.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Safety: will be evaluated by the incidence of Dose-related SAEs.
Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on
24 hours AND 7 days post-treatment; symptomatic stricture requiring an
additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic
stricture requiring endoscopic dilation at follow-up EGD; or any stricture
(symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at
follow-up EGD. Any other serious adverse events within 30 days after treatment
will also be evaluated by DSMB for relationship to the dose and severity.
2. Dose response (efficacy), which is defined as eradication percentage of BE
confirmed by histological evidence of eradication of BE, after two-step
circumferential treatment with the therapeutic dose. The eradication percentage
will be assessed by the EGD-Adjudication Committee, consisting of at least two
(2) physicians specialized in gastroenterology, by comparing pre-treatment and
follow-up digital images of the ablated areas in a systematic and standardized
manner.
Secondary outcome
1. Incidence of all serious and non-serious adverse events up to 30 days
post-treatment
2. Post-procedure pain in the area of the cryoablation treatment (scored on a 1
to 10- point VAS),
3. Efficacy, defined as the regression percentage at the first follow-up
endoscopy, after 1 treatment covering 50% of circumference with the therapeutic
dose
4. Efficacy of treatment with CryoBalloon Swipe Ablation System, defined as the
number of patients with a regression percentage of 80% or higher after
hemicircumferential treatment
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
endoscopies 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 current 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.
Additionally, patients may experience less pain after cryoablation compared
with other ablation techniques.
First, 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, three human trial has been performed with the Focal cryoablation
system which evaluated the safety of the this Focal system with several doses,
the device perfomance status, and the efficacy. The studies showed safe
treatment and high efficacy for cryoablation, with 100% eradication of Barretts
epithelium in the patients treated with the maximal dose (10 sec). Currently,
several trials are enrolling patients to study efficacy of the System even
better. Anyhow, this Focal system is only able to treat relatively little
Barrett*s Tissue. When ablating larger areas with this focal device an
important risk will exist that certain areas won*t be treated or just
overtreated and, additionally, it be a very time-consuming procedure.
Therefore the Swipe Sytem was recently introduced by C2 Therapeutics. This
device ablates a larger area in one ablation, thereby enabling the ablation of
larger BE tissue. This system was investigated in animal trials and in one
human trial, and it was judged to be safe. Now we want to study the efficacy of
the device in different doses, in order to find the efficacy at the optimal
dose.
Study objective
The objective of this study is to determine the safety and efficacy of the dose
required for eradication of LGD or HGD in BE, or residual BE after endoscopic
removal of early cancer (*therapeutic dose*), using the C2 CryoBalloon Swipe
System.
Study design
Prospective, mulit-center, single-arm and non-randomized clinical trial
Intervention
Endoscopic balloon based cryoablation. The System has three (3) main
components: a delivery catheter with a spray-hole covered by a balloon probe, a
single-use disposable handle and a cartridge containing the cryogenic fluid.
The catheter can be inserted into the working channel of a therapeutic
endoscope. Once deployed, the balloon is simultaneaously inflated and cooled
with cryogenic fluid from the cartridge. The BE cells of the esophagus will be
ablated if they come into contact with the cooled balloon. In the Swipe system,
the spray hole of the catheter will automatically be pulled back during
ablation. In this way, an area of 3 cm in length covering about 25% of the
circumference (depending on the size of the esophagus) will be freezed. The
dosing will be expressed in the speed (in mm/sec) whereby the catheter will be
pulled back during the ablation (lower speeds means a higher dose). In this
way, patients will be treated for 50% of their circumference (with 1-3
ablations necessary depending on the size of the esophagus) over a length of 3
cm.
Patients in phase I will undergo one single treatment, to treat 50% of
esophageal circumference. Patients in phase II (after the therapeutic dose will
be defined) will undergo a second treatment with the Swipe device to treat the
contrary 50% of esophageal circumference. This second treatment will be
performed 2 months after the first treatment.
Study burden and risks
Patients will undergo 2 to 3 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 (and the second, in case
of three endoscopies) patients will be treated with the swipe cryoablation
system instead of regular RFA treatment. During follow-up endoscopy a thorough
inspection of the esophagus and biopsies will be performed in accordance with
the standards of care. If necessary, additional treatment will be performed
with RFA. Patients need to adhere to a soft diet during 2 days after the
cryoablation. Furthermore patients will be contacted by telephone 2 and 7 days
after the cryoablation. Finally, patients may experience temporary limited
pain, which can be treated with paracetamol.
303 Convention Suite 1
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US
303 Convention Suite 1
Redwood City CA 94063
US
Listed location countries
Age
Inclusion criteria
1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
* Diagnosis of Low-grade dysplasia (LGD) or high-grade dysplasia (HGD) in BE (confirmed by baseline histopathological analysis), OR
* Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, *6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion, no lymphovascular infiltration, free vertical resection margins and not poorly differentiated)
2. Prague Classification Score C*3
3. Patients should be ablative-naïve, meaning they did not undergo any previous ablation therapy of the esophagus
4. Older than 18 years of age at time of consent
5. Operable per institution*s standards
6. Provides written informed consent on the IRB-approved informed consent form
7. Willing and able to comply with follow-up requirements
Exclusion criteria
1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope.
2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER >6 weeks prior to planned treatment under this protocol.
3. Prior ER >2cm in length and >50% of the esophageal lumen circumference
4. History of esophageal cancer (>T1a)
5. History of esophageal varices
6. Prior distal esophagectomy
7. Active esophagitis LA grade B or higher
8. Severe medical comorbidities precluding endoscopy
9. Uncontrolled coagulopathy
10. Pregnant or planning to become pregnant during period of study
11. Patient refuses or is unable to provide written informed consent
12. Participation in another study with investigational drug or device within the 30 days preceding or during the present study, interfering with participation in this trial
13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
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 | NL59918.018.16 |
| Other | Volgt |