Endoscopic Resection of Non-ampullary Duodenal Adenomas: Endoscopic Mucosal Resection (EMR) vs. Endoscopic Full-thickness Resection With the 'Duodenal Full-thickness Resection Device' (dFTRD)
NCT03559231 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2018-06-18
Summary
Prospective, randomized multi-center trial. Comparison of Endoscopic Mucosal Resection (EMR) versus Endoscopic Full-Thickness Resection with the duodenal Full-Thickness Resection Device (dFTRD) of non-ampullary duodenal adenomas.
Conditions
- Duodenal Adenoma
Interventions
- PROCEDURE
-
dFTRD
Duodenal Full-Thickness Resection
- PROCEDURE
-
EMR
Endoscopic Mucosal Resection
Sponsors & Collaborators
-
Kliniken Ludwigsburg-Bietigheim gGmbH
lead OTHER
Principal Investigators
-
Karel Caca, MD, PhD · Klinikum Ludwigsburg
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-05-12
- Primary Completion
- 2020-06-12
- Completion
- 2021-05-12
Countries
- Germany
Study Locations
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