NCT06192355

Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.

One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University Hospital Augsburg · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.

Detailed description

Acute upper gastrointestinal bleeding is a common medical emergency. According to guidelines, endoscopic evaluation should be performed within 24 hours. With an overall high incidence and an overall high number of diagnostic and therapeutic endoscopic procedures, the introduction of new endoscopic concepts may have a profound impact on outcomes as well as cost-effectiveness in upper gastrointestinal bleeding. For this purpose, the use of single-use gastroscopes represents an interesting possibility. Hygiene issues in the emergency situation are also relevant. The previous feasibility study One-Scope I demonstrated that the diagnosis as well as the therapy of upper gastrointestinal bleeding is possible with single-use gastroscopes. In this follow-up study, the investigators compare the use of single-use versus reusable gastroscopes in participants with suspected upper gastrointestinal bleeding in a randomized controlled trial.

Conditions

• Upper Gastrointestinal Bleeding

Interventions

Type	Name	Description
DEVICE	Endoscopic hemostasis using a Esophagogastroduodenoscopy	performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

Timeline

• Start date: 2023-03-27
• Primary completion: 2024-11-01
• Completion: 2025-01-01
• First posted: 2024-01-05
• Last updated: 2024-01-31

Locations

1 site across 1 country: Germany