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

NCT ID: NCT06192355

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-27
• Study Completion Date: 2025-01-01

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.

Conditions

Upper Gastrointestinal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single-use gastroscope

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

Group Type: EXPERIMENTAL

Endoscopic hemostasis using a Esophagogastroduodenoscopy

Intervention Type: DEVICE

performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

reusable gastroscope

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

Group Type: ACTIVE_COMPARATOR

Endoscopic hemostasis using a Esophagogastroduodenoscopy

Intervention Type: DEVICE

performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

Interventions

Endoscopic hemostasis using a Esophagogastroduodenoscopy

performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• pregnancy
• Unable to provide consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Augsburg

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christoph Römmele, MD

Role: PRINCIPAL_INVESTIGATOR

Unervsity Hospital Augsburg

Locations

University Hospital of Augsburg

Augsburg, Bavaria, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Christoph Römmele, MD

Role: CONTACT

christoph.roemmele@uk-augsburg.de

+498214002351

Alanna Ebigbo, MD

Role: CONTACT

alanna.ebigbo@uk-augsburg.de

Facility Contacts

Christoph Römmele, MD

Role: primary

christoph.roemmele@uk-augsburg.de

+498214002351

Alanna Ebigbo, MD

Role: backup

alanna.ebigbo@uk-augsburg.de

Other Identifiers

00000013

Identifier Type: -

Identifier Source: org_study_id