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

Colorectal Adenomas Clinical Trial

— WALL-RESECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02362126
• Other study ID #: WALL-RESECT
• Status: Recruiting
• Phase: N/A
• First received: February 7, 2015
• Last updated: February 11, 2015
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2015
• Source: Kliniken Ludwigsburg-Bietigheim gGmbH
• Contact: Arthur R Schmidt, MD
• Phone: 0049 (0) 7141 99 67201
• Email: arthur.schmidt[@]kliniken-lb.de
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Adenomas
• Submucosal Tumors

Intervention

Device:
• Endoscopic full thickness resection (EFTR)
Patients undergo EFTR using the FTRD

Locations

Country	Name	City	State
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg

Sponsors (2)

Lead Sponsor	Collaborator
Kliniken Ludwigsburg-Bietigheim gGmbH	Ovesco Endoscopy, Tübingen, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Schmidt A, Damm M, Caca K. Endoscopic full-thickness resection using a novel over-the-scope device. Gastroenterology. 2014 Oct;147(4):740-742.e2. doi: 10.1053/j.gastro.2014.07.045. Epub 2014 Jul 30. — View Citation

Schurr MO, Baur FE, Krautwald M, Fehlker M, Wehrmann M, Gottwald T, Prosst RL. Endoscopic full-thickness resection and clip defect closure in the colon with the new FTRD system: experimental study. Surg Endosc. 2015 Aug;29(8):2434-41. doi: 10.1007/s00464-014-3923-x. Epub 2014 Oct 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical success	Successful enbloc- and macroscopically complete resection	Immediate	No
Primary	R0-Resection	Histologically confirmed complete resection	3 days	No
Secondary	Histologically confirmed full thickness resection	Histologically confirmed full thickness resection	3 days	No
Secondary	Procedure-associated complications	Procedure-associated complications such as bleeding or perforation	3 months	Yes
Secondary	Procedure time	Procedure time	immediate	No
Secondary	Necessity of surgical treatment		3 months	No
Secondary	Residual or recurrent adenoma/carcinoma at endoscopic follow up		3 months	No