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Endoscopic Treatment of Non-variceal Upper GI-bleeding With High Risk of Recurrency - OTSC (Over-the-scope-clip) Versus Standard Therapy (STING2)

NCT03331224 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2017-11-06

No results posted yet for this study

Summary

Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified and 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

OTSC

OTSC placement

DEVICE

Endoscopic Standard therapy (combining two methods)

endoscopic standard therapy (two methods, e.g. clip and injection)

Sponsors & Collaborators

  • University Hospital Freiburg

    collaborator OTHER

  • University Hospital Ulm

    collaborator OTHER

  • University Hospital Goettingen

    collaborator OTHER

  • Evangelisches Krankenhaus Düsseldorf

    collaborator OTHER

  • University Hospital, Essen

    collaborator OTHER

  • University of Leipzig

    collaborator OTHER

  • University Hospital Tuebingen

    collaborator OTHER

  • Kliniken Ludwigsburg-Bietigheim gGmbH

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2019-09-01
Completion
2019-09-01

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 NCT03331224 on ClinicalTrials.gov