Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy
NCT01836900 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64
Last updated 2013-04-22
Summary
Prospective-randomized trial. Patients with recurrent bleeding from gastroduodenal ulcers are randomized into either endoscopic treatment with the OTSC \[Over The Scope Clip\] or endoscopic standard therapy. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.
Conditions
- Acute Upper Gastrointestinal Hemorrhage
Interventions
- DEVICE
-
Endoscopic hemostasis
Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution
Sponsors & Collaborators
-
University Hospital Tuebingen
collaborator OTHER -
University Hospital Augsburg
collaborator OTHER -
Marienkrankenhaus Frankfurt
collaborator OTHER -
Klinikum Stadt Hanau
collaborator OTHER -
Klinikum Garmisch-Patenkirchen
collaborator OTHER -
University of Zurich
collaborator OTHER -
Universitätsklinikum Hamburg-Eppendorf
collaborator OTHER -
Kliniken Ludwigsburg-Bietigheim gGmbH
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-03-31
- Primary Completion
- 2015-03-31
- Completion
- 2015-04-30
Countries
- Germany
Study Locations
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