Clinical trial to investigate the safety and efficacy of the cryoballon swipe ablation system
- Conditions
- Barrett's esophagus, Barrett's dysplasia, Cryo ablation, Cryo therapy, Barrett's slokdarm, Barrett gerelateerde dysplasia, Cryo ablatie, Cryo therapie
- Registration Number
- NL-OMON23166
- Lead Sponsor
- C2 Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 18
Inclusion Criteria
1.Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning:
•Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1)Safety will be evaluated by the incidence of Dose-related SAEs<br /><br>2)Efficacy (eradication percentage as determined with the EGD-AC plus histological evidence of eradication of BE, after circumferential treatment with the therapeutic dose).
- Secondary Outcome Measures
Name Time Method 1.Incidence of all serious and non-serious adverse events up to 30 days post-treatment<br /><br>2.Post-procedure pain in the area of the cryoablation treatment (scored on a 1 to 10- point VAS), <br /><br>3.Efficacy, defined as the regression percentage at the first follow-up endoscopy, after 1 treatment covering 50% of circumference, with the therapeutic dose<br /><br>4.Efficacy for treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with >80% regression of BE after 1 semicircumferential resp. fully circumferential treatment