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

No results posted yet for this study

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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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01836900 on ClinicalTrials.gov