Neoplasms

All Conditions

Adenoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors

Endoscopic full thickness resection (EFTR)

Arthur R Schmidt, MD

Karel Caca, MD, PhD

Arthur Schmidt, MD

Karel Caca, Prof.

Arthur R Schmidt, Dr.

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.

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

Successful enbloc- and macroscopically complete resection

Histologically confirmed complete resection

Histologically confirmed full thickness resection

Procedure-associated complications such as bleeding or perforation

Ovesco Endoscopy AG

Kliniken Ludwigsburg-Bietigheim gGmbH

Digestive System Diseases

Rare Diseases

Gastrointestinal Stromal Tumors

Resection of the gastric GIST by ESD techniques followed by endoscopic closure of defect with suturing or clips and loop

Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure

Endoscopic Full Thickness Resection

Philip Wai Yan Y Chiu, MD, FRCSEd

Man Yee Yung

Philip WY Chiu, MD

Philip Wai Yan Chiu, MD, FRCSEd

This is a clinical trial to evaluate the efficacy and safety of endoscopic full thickness resection for treatment of gastric GIST

To evaluate the clinical safety and efficacy of endoscopic full thickness resection (EFTR) for treatment of gastric GIST. A total of 30 patients will be recruited

Endoscopic Full Thickness Resection for Gastric GIST

Prospective Clinical Study on Safety and Effectiveness of Endoscopic Full Thickness Resection for Treatment of Patients With Gastric Gastrointestinal Stromal Tumors (GIST)

Complete resection of the GIST defined by en-bloc resection in one piece by endoscopy with clear resection margins

Adverse event as defined by presence of either postoperative bleeding or leakage after closure

Histology outcome as defined by any involvement of the tumor margins after resection

Technical success defined by complete endoscopic resection, closure of the defect and delivery of the specimen per orally without need of conversion to laparoscopic surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"	NCT02362126	Colorectal Aden... Submucosal Tumo...	Endoscopic full...	18 Years -	Kliniken Ludwigsburg-Bietigheim gGmbH
Endoscopic Full Thickness Resection for Gastric GIST	NCT04198337	Gastric GIST	Endoscopic Full...	18 Years - 80 Years	Chinese University of Hong Kong
Endoscopic Full Thickness Resection for Gastric GIST	NCT04198337	Gastric GIST	Endoscopic Full...	18 Years - 80 Years	Chinese University of Hong Kong

Spots Global Cancer Trial Database for endoscopic full thickness resection