Study on the Safety, Tolerability and Efficacy of the Aqua Medical focal vapor ablation system, for the eradication of Barrett*s Esophagus - part 2

Phase 2

Completed

• Conditions: Esophageal Carcinoma; Intestinal Metaplasia; 10017990; 10017991

• Registration Number: NL-OMON55125
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 28

Inclusion Criteria

Adult patients with Barrett esophagus and early neoplasia, with an indication
for endoscopic treatment

Exclusion Criteria

Patients with prior ablation therapy or contra-indications for ablation
therapy. Subjects with any condition that in the opinion of the PI preclude
enrollment into the trial,

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety:<br /><br>Safety will be assessed by the incidence and severity of any complications that<br /><br>are associated with the vapor ablation throughout the follow-up period.<br /><br>Included in this assessment will be the proportion of subjects with any of the<br /><br>following outcomes from initiations of vapor ablation therapy and completion of<br /><br>the 6-8 week evaluation: (1) death, or (2) medical morbidity associated with<br /><br>the device and/or vapor ablation, including perforation, hemorrhage, scarring<br /><br>or stricture formation.<br /><br><br /><br>Efficacy: The primary efficacy endpoint is the complete regression of BE<br /><br>mucosa, assessed through endoscopic imagery and histologic evaluation.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Other evaluations include, but are not limited to the following: • Deployment<br /><br>ease/scope compatibility. • Device malfunctions. • Time of catheter deployment.<br /><br>• Adverse events. • Stricture formation at 6 to 8 weeks. • Patient Pain. •<br /><br>Histological evaluation of treatment zone at 6 to 8 weeks for presence of<br /><br>residual Barrett*s Esophagus.</p><br>