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| Name | Class |
|---|---|
| Ovesco Endoscopy AG | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients undergoing EFTR | Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic full thickness resection (EFTR) | Device | Patients undergo EFTR using the FTRD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Technical success | Successful enbloc- and macroscopically complete resection | Immediate |
| R0-Resection | Histologically confirmed complete resection | 3 days |
| Measure | Description | Time Frame |
|---|---|---|
| Histologically confirmed full thickness resection | Histologically confirmed full thickness resection | 3 days |
| Procedure-associated complications | Procedure-associated complications such as bleeding or perforation |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with colorectal lesions which are difficult or impossible to resect with conventional endoscopic methods
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Arthur R Schmidt, MD | Contact | 0049 (0) 7141 99 67201 | arthur.schmidt@kliniken-lb.de | |
| Karel Caca, MD, PhD | Contact | 0049 (0) 7141 99 67201 | karel.caca@kliniken-lb.de |
| Name | Affiliation | Role |
|---|---|---|
| Karel Caca, MD, PhD | Klinikum Ludwigsburg, Department of Gastroenterology | Study Chair |
| Arthur R Schmidt, MD | Klinikum Ludwigsburg, Department of Gastroenterology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Klinikum Ludwigsburg | Recruiting | Ludwigsburg | Baden-Wurttemberg | 71640 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25318369 | Background | 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. | |
| 25083605 | Background |
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| ID | Term |
|---|---|
| D000069916 | Endoscopic Mucosal Resection |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| 3 months |
| Procedure time | Procedure time | immediate |
| Necessity of surgical treatment | 3 months |
| Residual or recurrent adenoma/carcinoma at endoscopic follow up | 3 months |
| 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. No abstract available. |
| 32816955 | Derived | Kuellmer A, Behn J, Beyna T, Schumacher B, Meining A, Messmann H, Neuhaus H, Albers D, Birk M, Probst A, Faehndrich M, Frieling T, Goetz M, Thimme R, Caca K, Schmidt A. Endoscopic full-thickness resection and its treatment alternatives in difficult-to-treat lesions of the lower gastrointestinal tract: a cost-effectiveness analysis. BMJ Open Gastroenterol. 2020 Aug;7(1):e000449. doi: 10.1136/bmjgast-2020-000449. |
| 28798042 | Derived | Schmidt A, Beyna T, Schumacher B, Meining A, Richter-Schrag HJ, Messmann H, Neuhaus H, Albers D, Birk M, Thimme R, Probst A, Faehndrich M, Frieling T, Goetz M, Riecken B, Caca K. Colonoscopic full-thickness resection using an over-the-scope device: a prospective multicentre study in various indications. Gut. 2018 Jul;67(7):1280-1289. doi: 10.1136/gutjnl-2016-313677. Epub 2017 Aug 10. |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |