Clinical trial to evaluate safety and dose response of the C2 CryoBalloon 180 Ablation System
Recruiting
- Conditions
- Barrett's esophagus<br />Barrett's dysplasia<br />Cryoablation<br />Cryotherapy<br /><br />Barrett slokdarm<br />Barrett neoplasie<br />Cryoablatie<br />Cryotherapie
- Registration Number
- NL-OMON28028
- Lead Sponsor
- C2 Therapeutics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
- Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR
Exclusion Criteria
1. Esophageal stenosis 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 by the EGDAdjudication Committee 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 epigastric or chest pain from the cryoablation treatment (0-10 VAS score), described as the mean and median pain scores at 24 hours and seven (7) days post-procedure.<br /><br>3. Efficacy, defined as the regression percentage at the first followup endoscopy (after one (1) treatment covering 50% of the esophageal circumference, with the therapeutic dose)<br /><br>4. Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 semi-circumferential and after fully circumferential treatment.