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

University Hospital Augsburg

Status: Enrolling

Conditions: Upper Gastrointestinal Bleeding

Treatments: Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT06192355

00000013

Details and patient eligibility

About

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

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Glasgow-Blatchford score (GBS) >2
• Clinical signs of upper bleeding

Exclusion criteria

• pregnancy
• Unable to provide consent

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Single-use gastroscope

Experimental group

Description:

A disposable endoscope designed for a one-time use during a Gastroscopy, eliminating the need for reprocessing or sterilization. After a single procedure, the entire gastroscope is discarded, reducing the risk of cross-contamination and ensuring a fresh, sterile instrument for each patient intervention

Treatment:

Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy

reusable gastroscope

Active Comparator group

Description:

A durable endoscope designed for multiple uses after thorough reprocessing and sterilization

Treatment:

Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy