One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- intraprocedural technical success
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Glasgow-Blatchford score (GBS) >2
- •Clinical signs of upper bleeding
Exclusion Criteria
- •pregnancy
- •Unable to provide consent
Outcomes
Primary Outcomes
intraprocedural technical success
Time Frame: Up to 20 minutes
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
Secondary Outcomes
- Length of intervention(Up to 60 minutes)
- blood transfusions(Up to 30 days)
- re-bleeding rate(Up to 30 days)
- Length of Stay(Up to 30 days)
- intraprocedural clinical success(Up to 45 Minutes)
- Adverse events(Up to 30 days)
- cross over to reusable gastroscope(Up to 60 Minutes)