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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Observational

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

Brief 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 Summary:

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.


Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH

Current Primary Outcome:

  • Technical success [ Time Frame: Immediate ]
    Successful enbloc- and macroscopically complete resection
  • R0-Resection [ Time Frame: 3 days ]
    Histologically confirmed complete resection


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Histologically confirmed full thickness resection [ Time Frame: 3 days ]
    Histologically confirmed full thickness resection
  • Procedure-associated complications [ Time Frame: 3 months ]
    Procedure-associated complications such as bleeding or perforation
  • Procedure time [ Time Frame: immediate ]
    Procedure time
  • Necessity of surgical treatment [ Time Frame: 3 months ]
  • Residual or recurrent adenoma/carcinoma at endoscopic follow up [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Kliniken Ludwigsburg-Bietigheim gGmbH

Dates:
Date Received: February 7, 2015
Date Started: February 2015
Date Completion: February 2017
Last Updated: February 11, 2015
Last Verified: February 2015