- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03331224
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 Contact
- Name: Karel Caca, Prof
- Phone Number: 004971419967201
- Email: karel.caca@kliniken-lb.de
Study Locations
-
-
-
Ludwigsburg, Germany
- Recruiting
- Klinikum Ludwigsburg
-
Contact:
- Benjamin Meier
- Phone Number: 004971419967201
- Email: benjamin.meier@kliniken-lb.de
-
Contact:
- Karel Caca
- Phone Number: 004971419967201
- Email: karel.caca@kliniken-lb.de
-
Principal Investigator:
- Karel Caca, Prof.
-
-
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.
|
OTSC placement
|
ACTIVE_COMPARATOR: Standard therapy
Endoscopic standard therapy (two techniques e.g.
clip and injection)
|
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.
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.
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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