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.
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.
Study Type
OBSERVATIONAL
Enrollment
80
Patients undergo EFTR using the FTRD
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, Germany
RECRUITINGTechnical success
Successful enbloc- and macroscopically complete resection
Time frame: Immediate
R0-Resection
Histologically confirmed complete resection
Time frame: 3 days
Histologically confirmed full thickness resection
Histologically confirmed full thickness resection
Time frame: 3 days
Procedure-associated complications
Procedure-associated complications such as bleeding or perforation
Time frame: 3 months
Procedure time
Procedure time
Time frame: immediate
Necessity of surgical treatment
Time frame: 3 months
Residual or recurrent adenoma/carcinoma at endoscopic follow up
Time frame: 3 months
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