Barrett's esophagus esophageal cancer
Conditions
Interventions
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 cont
Sponsors
C2Therapeutics, Marcia Wachna
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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
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 outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Outcome results
None listed