Endoscopic Treatment of Recurrent Upper GI Bleeding: OTSC [Over the Scope Clip] Versus Standard Therapy (STING)
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ClinicalTrials.gov Identifier: NCT01836900 |
Recruitment Status : Unknown
Verified April 2013 by Kliniken Ludwigsburg-Bietigheim gGmbH.
Recruitment status was: Recruiting
First Posted : April 22, 2013
Last Update Posted : April 22, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Upper Gastrointestinal Hemorrhage | Device: Endoscopic hemostasis | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 64 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Endoscopic Treatment of Recurrent Upper GI Bleeding From Gastroduodenal Ulcers: OTSC [Over the Scope Clip] Versus Standard Therapy |
Study Start Date : | March 2013 |
Estimated Primary Completion Date : | March 2015 |
Estimated Study Completion Date : | April 2015 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Standard Therapy
Endoscopic therapy with Standard Clip + injection of epinephrine solution or thermal therapy + injection of epinephrin-solution
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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 |
Experimental: OTSC (Over The Scope Clip)
Endoscopic therapy with Application of OTSC Clip and Injection of epinephrin-solution
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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 |
- Persistent bleeding or Rebleeding with 7 days [ Time Frame: 7 days ]
- blood units transfused [ Time Frame: 30 days ]
- duration of hospital stay [ Time Frame: 30 days ]
- duration of intensive care unit stay [ Time Frame: 30 days ]
- 30 d Mortality [ Time Frame: 30 days ]
- Amount of endoscopic reinterventions [ Time Frame: 7 d ]
- Necessity of surgical or angiographic therapy [ Time Frame: 7 d ]
- Complications during or after OTSC (Over The Scope Clip) placement [ Time Frame: 7 d ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Recurrence of bleeding from gastroduodenal ulcers
Exclusion Criteria:
- Malignant ulcers, variceal bleeding, patients younger than 18 years, lesions not suitable for treatment with OTSC

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836900
Contact: Karel Caca, Prof. Dr. | +49714167201 | karel.caca@kliniken-lb.de | |
Contact: Arthur Schmidt, Dr. | +49714167201 | arthur.schmidt@kliniken-lb.de |
Germany | |
Klinikum Ludwigsburg | Recruiting |
Ludwigsburg, Germany, 71640 | |
Contact: Arthur Schmidt, Dr +49714167201 arthur.schmidt@klinken-lb.de | |
Contact: Katja Hahmann-Dolle, Dr. +49714167201 katja.hahmann-dolle@klinken-lb.de | |
Sub-Investigator: Arthur Schmidt, Dr. |
Responsible Party: | Kliniken Ludwigsburg-Bietigheim gGmbH |
ClinicalTrials.gov Identifier: | NCT01836900 |
Other Study ID Numbers: |
STING |
First Posted: | April 22, 2013 Key Record Dates |
Last Update Posted: | April 22, 2013 |
Last Verified: | April 2013 |
OTSC Upper gastrointestinal bleeding |
Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Gastrointestinal Diseases |
Digestive System Diseases Hemostatics Coagulants |