PreCap-study

Completed

Conditions: Barrett's esophagus
early cancer
high grade dysplasia
endoscopic resection.in Dutch: Barrett slokdarm, vroegkanker, hooggradige dysplasie, endoscopische resectie

Registration Number: NL-OMON23426

Lead Sponsor: Academic Medial center Amsterdam, the Netherlands

Brief Summary: Published in surgical endoscopy

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 11

Inclusion Criteria

Phase I

1.Age 18-80 years

Exclusion Criteria

Phase I

1.Subject has previously undergone endoscopic therapy in the intended treatment zone, including (but not limited to) cryospray therapy, laser treatment, photodynamic therapy, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Phase I<br /><br>1)Maximum diameter of the resection specimens retrieved with the CaptivatorTM -and DuetteTM devices.<br><br /><br /><br>Phase II<br /><br>1)Percentage of successful endoscopic resection (i.e. resection of all lesion delineation markings)<br>

Secondary Outcome Measures

Name	Time	Method
Phase I<br /><br>1)Difference in the number of device or procedure related complications, such as bleeding or perforation, experienced with the CaptivatorTM device compared to the DuetteTM device.<br /><br>2)Visibility of the CaptivatorTM device and the DuetteTM device (pre- and post-procedure).<br /><br>3)Ease of endoscopic resection<br /><br>4)Procedure time<br /><br><br /><br>Phase II<br /><br>1)Number and severity of any acute (during procedure) or early (0-48 hours) device or procedure related complications such as bleeding or perforation during endoscopic resection with the CaptivatorTM device. Complications are registered only if they are clinically significant.<br /><br>2)Presence of any late complications (> 48 hours) such as bleeding or perforation during endoscopic resection with the CaptivatorTM device. Complications are registered only if they are clinically significant.<br /><br>3)Procedure time<br>