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

October 31, 2017 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Prospective-randomized multi-center trial. Patients with high risk of recurrent GI-bleeding (non-variceal) are identified (Rockall Score > 6) and randomized into either endoscopic treatment with the OTSC [Over The Scope Clip] or endoscopic standard therapy. 100 Patients are planned. Hypothesis: Endoscopic therapy with OTSC is superior to standard therapy regarding technical success and rebleeding.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • upper GI-bleeding (non-variceal) with high risk of recurrency
  • 18 years and older

Exclusion Criteria:

  • variceal-bleeding
  • under 18 years
  • pregnancy or nursing period
  • malignancy
  • need for surgical treatment (for example perforation with peritonitis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OTSC
Initial treatment with the OTSC for non-variceal upper GI-bleedings with high risk of recurrency.
Device: OTSC
OTSC placement
ACTIVE_COMPARATOR: Standard therapy
Endoscopic standard therapy (two techniques e.g. clip and injection)
Device: Endoscopic Standard therapy (combining two methods)
endoscopic standard therapy (two methods, e.g. clip and injection)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistent bleeding or Rebleeding with 7 days
Time Frame: 7 days
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
blood units transfused
Time Frame: 30 days
30 days
duration of hospital stay
Time Frame: 30 days
30 days
duration of intensive care unit stay
Time Frame: 30 days
30 days
30 d Mortality
Time Frame: 30 days
30 days
Amount of endoscopic reinterventions
Time Frame: 7 days
7 days
Necessity of surgical or angiographic therapy
Time Frame: 7 days
7 days
Complications during or after OTSC (Over The Scope Clip) placement
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Collaborators

University Hospital, Essen
University of Leipzig
University Hospital Tuebingen
University Hospital Freiburg
University Hospital Ulm
Evangelisches Krankenhaus Düsseldorf
University Hospital Goettingen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2017

Primary Completion (ANTICIPATED)

September 1, 2019

Study Completion (ANTICIPATED)

September 1, 2019

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (ACTUAL)

November 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 6, 2017

Last Update Submitted That Met QC Criteria

October 31, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STING2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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