NL-OMON48956
Completed
Not Applicable
Clinical trial to evaluate safety and dose response using the C2 CryoBalloonTM 180 Ablation system for the treatment of dysplastic Barrett*s esophagus - C2 CryoBalloon 180 Ablation System Dose Response Study
C2 Therapeutics, contactpersoon Marcia Wachna0 sites25 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- C2 Therapeutics, contactpersoon Marcia Wachna
- Enrollment
- 25
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients must meet ALL of the following criteria to be eligible for
- •participation in the study:
- •1\. Flat\- type BE esophagus, with an indication for ablation therapy, defined as:
- •a. Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological
- •analysis), OR
- •b. Residual BE with any grade of dysplasia after endoscopic resection (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 or limited submucosal invasion (SM1\), no lymphovascular infiltration,
- •free vertical resection margins and not poorly differentiated)
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.
- •3\. Prior ER of more than 2cm in length or \>50% of the esophageal lumen
- •circumference
- •4\. History of locally advanced (\>SM1\) esophageal cancer
- •5\. History of esophageal varices
- •6\. Prior distal esophagectomy
- •7\. Active esophagitis LA grade B or higher
Outcomes
Primary Outcomes
Not specified
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