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

Upper Gastrointestinal Bleeding Clinical Trial

— OneScopeII  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06192355
• Other study ID #: 00000013
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2023
• Est. completion date: January 1, 2025

Study information

• Verified date: January 2024
• Source: University Hospital Augsburg
• Contact: Christoph Römmele, MD
• Phone: +498214002351
• Email: christoph.roemmele[@]uk-augsburg.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: January 1, 2025
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Glasgow-Blatchford score (GBS) >2

• Clinical signs of upper bleeding

Exclusion Criteria:

• pregnancy

• Unable to provide consent

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

Device:
• Endoscopic hemostasis using a Esophagogastroduodenoscopy
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

Locations

Country	Name	City	State
Germany	University Hospital of Augsburg	Augsburg	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Augsburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	intraprocedural technical success	defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site	Up to 20 minutes
Secondary	intraprocedural clinical success	defined as successful endoscopic hemostasis during the examination if required	Up to 45 Minutes
Secondary	re-bleeding rate	need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding	Up to 30 days
Secondary	blood transfusions	Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels = 70 g/L	Up to 30 days
Secondary	Length of Stay	Duration of inpatient stay, measured from the day of admission to the day of discharge	Up to 30 days
Secondary	Length of intervention	measured from initiation to achievement of hemostasis	Up to 60 minutes
Secondary	cross over to reusable gastroscope	Switch to a reusable gastroscope in case of non-achieved technical or clinical success, such as unsuccessful hemostasis, insufficient assessment of the bleeding source, or inability to reach the descending duodenum	Up to 60 Minutes
Secondary	Adverse events	Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.	Up to 30 days