Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device" (WALL-RESECT)

Kliniken Ludwigsburg-Bietigheim gGmbH

Status

Unknown

Conditions

Submucosal Tumors

Colorectal Adenomas

Treatments

Device: Endoscopic full thickness resection (EFTR)

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT02362126

WALL-RESECT

Details and patient eligibility

About

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.

Full 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.

Enrollment

80 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age > 18 y
Adenoma with negtive lifting sign
Adenoma involving or next to a diverticulum
Adenoma involving or next to the appendical orifice
T1 carcinoma with indication for endoscopic (re-)resection
Subepithelial colorectal tumor with indication for resection

Exclusion criteria

Lesions >3 cm
T1 carcinomas with known high-risk features (submucosal infiltration>1000 um, invasion of lymphatic vessels, poor differentiation (G3))
Lesions in the upper GI tract
Patients with colorectal stenosis
Patinets not able to undergo informed consent
Pregnancy
Patients with urgent indication for dual thrombocyte aggregation inhibition