NCT03331224

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Kliniken Ludwigsburg-Bietigheim gGmbH · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Acute Upper Gastrointestinal Hemorrhage

Interventions

Type	Name	Description
DEVICE	OTSC	OTSC placement
DEVICE	Endoscopic Standard therapy (combining two methods)	endoscopic standard therapy (two methods, e.g. clip and injection)

Timeline

• Start date: 2017-09-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2017-11-06
• Last updated: 2017-11-06

Locations

1 site across 1 country: Germany