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.
1 other identifier
interventional
150
1 country
1
Brief Summary
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 27, 2023
CompletedFirst Submitted
Initial submission to the registry
May 12, 2023
CompletedFirst Posted
Study publicly available on registry
January 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJanuary 31, 2024
January 1, 2024
1.6 years
May 12, 2023
January 29, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
intraprocedural technical success
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
Up to 20 minutes
Secondary Outcomes (7)
intraprocedural clinical success
Up to 45 Minutes
re-bleeding rate
Up to 30 days
blood transfusions
Up to 30 days
Length of Stay
Up to 30 days
Length of intervention
Up to 60 minutes
- +2 more secondary outcomes
Study Arms (2)
Single-use gastroscope
EXPERIMENTALA 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
reusable gastroscope
ACTIVE COMPARATORA durable endoscope designed for multiple uses after thorough reprocessing and sterilization
Interventions
performing an Esophagogastroduodenoscopy for diagnosis and therapy of possible bleeding sites
Eligibility Criteria
You may qualify if:
- Glasgow-Blatchford score (GBS) \>2
- Clinical signs of upper bleeding
You may not qualify if:
- pregnancy
- Unable to provide consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Augsburg
Augsburg, Bavaria, 86156, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Römmele, MD
Unervsity Hospital Augsburg
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2023
First Posted
January 5, 2024
Study Start
March 27, 2023
Primary Completion
November 1, 2024
Study Completion
January 1, 2025
Last Updated
January 31, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share