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

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

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

Study Overview

• Status: Recruiting
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christoph Römmele, MD; Phone Number: +498214002351; Email: christoph.roemmele@uk-augsburg.de
• Study Contact Backup: Name: Alanna Ebigbo, MD; Email: alanna.ebigbo@uk-augsburg.de

Study Locations

• Germany
  • Bavaria
    • Augsburg, Bavaria, Germany, 86156
      • Recruiting
      • University Hospital of Augsburg
      • Contact: Christoph Römmele, MD; Phone Number: +498214002351; Email: christoph.roemmele@uk-augsburg.de
      • Contact: Alanna Ebigbo, MD; Email: alanna.ebigbo@uk-augsburg.de
      • Principal Investigator: Christoph Römmele, MD
      • Sub-Investigator: Alanna Ebigbo, MD
      • Sub-Investigator: Vidan Tadic, MD
      • Sub-Investigator: Helmut Messmann, MD
      • Sub-Investigator: Mousa Ayoub, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

• pregnancy
• Unable to provide consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy; performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites
Active Comparator: reusable gastroscope; A durable endoscope designed for multiple uses after thorough reprocessing and sterilization	Device: Endoscopic hemostasis using a Esophagogastroduodenoscopy; performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraprocedural technical success	defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site	Up to 20 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
intraprocedural clinical success	defined as successful endoscopic hemostasis during the examination if required	Up to 45 Minutes
re-bleeding rate	need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding	Up to 30 days
blood transfusions	Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L	Up to 30 days
Length of Stay	Duration of inpatient stay, measured from the day of admission to the day of discharge	Up to 30 days
Length of intervention	measured from initiation to achievement of hemostasis	Up to 60 minutes
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
Adverse events	Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.	Up to 30 days

Collaborators and Investigators

• Sponsor: University Hospital Augsburg
• Investigators: Principal Investigator: Christoph Römmele, MD, Unervsity Hospital Augsburg

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2023
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: May 12, 2023
• First Submitted That Met QC Criteria: December 20, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Endoscopy; Emergency
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage; Coagulants; Hemostatics
• Other Study ID Numbers: 00000013

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No