NCT02362126

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"

Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"- A Prospective Multicenter Trial

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Observational prospective multicenter study to investigate efficacy and safety of endoscopic full thickness resection in the lower GI tract using a novel over-the-scope full thickness resection device.

Detailed description

The FTRD ("Full Thickness Resection Device", Ovesco Endoscopy, Tübingen, Germany) is an over the scope device consisting of a transparent cap with a preloaded monofilament snare and and a 14 mm modified Over-the-scope Clip. The device is CE marked for full thickness resection in the lower GI tract. The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.

Conditions

• Colorectal Adenomas
• Submucosal Tumors

Interventions

Type	Name	Description
DEVICE	Endoscopic full thickness resection (EFTR)	Patients undergo EFTR using the FTRD

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-02-01
• Completion: 2017-02-01
• First posted: 2015-02-12
• Last updated: 2015-02-12

Locations

1 site across 1 country: Germany