NL-OMON28028
Recruiting
Not Applicable
Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Barrett's esophagus<br />Barrett's dysplasia<br />Cryoablation<br />Cryotherapy<br /><br />Barrett slokdarm<br />Barrett neoplasie<br />Cryoablatie<br />Cryotherapie
- Sponsor
- C2 Therapeutics, Inc.
- Enrollment
- 25
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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Clinical trial to evaluate safety and dose response using the C2 CryoBalloonTM 180 Ablation system for the treatment of dysplastic Barrett*s esophagusNL-OMON48956C2 Therapeutics, contactpersoon Marcia Wachna25
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