Endoscopic Full Thickness Resection in the Lower GI Tract With the "Full Thickness Resection Device"
NCT ID: NCT02362126
Last Updated: 2015-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2015-02-28
2017-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Endoscopic Full-thickness Resection of Gastric Subepithelial Tumors With the gFTRD
NCT03096236
Gastroduodenal Full Thickness Resection Device Registry - gdFTRD® Registry
NCT07142902
Technical Failure During Colorectal Endoscopic Full Thickness Resection (EFTR): The "Through Thick and Thin" Study
NCT05913453
Full Thickness Resection or Endoscopic Submucosal Dissection for Difficult Colorectal Lesions.
NCT05502276
Endoscopic Full-Thickness Resection In Colon
NCT03803891
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The study was designed to investigate efficacy and safety of this device for full thickness resection of colorectal lesions.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients undergoing EFTR
Patients with non-lifting adenomas, adnomas at difficult anaotomic locations , T1-carcinomas or submucosal colorectal tumors
Endoscopic full thickness resection (EFTR)
Patients undergo EFTR using the FTRD
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Endoscopic full thickness resection (EFTR)
Patients undergo EFTR using the FTRD
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ovesco Endoscopy AG
INDUSTRY
Kliniken Ludwigsburg-Bietigheim gGmbH
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Karel Caca, MD, PhD
Role: STUDY_CHAIR
Klinikum Ludwigsburg, Department of Gastroenterology
Arthur R Schmidt, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum Ludwigsburg, Department of Gastroenterology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Klinikum Ludwigsburg
Ludwigsburg, Baden-Wurttemberg, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
WALL-RESECT
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.