An interventional study of Endoscopic hemostasis using a Esophagogastroduodenoscopy in Upper Gastrointestinal Bleeding, sponsored by University Hospital Augsburg. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-31.
Sponsored by University Hospital Augsburg · Not applicable, Interventional, and Diagnostic
Controlled-randomized trial evaluating single-use versus reusable gastroscopes in patients with upper gastrointestinal bleeding.
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.
339 studies on the registry are indexed under Gastrointestinal Hemorrhage; 79 are open to participants now.
This study's planned enrollment of 150 is above the median of 87 across 211 interventional studies indexed under Gastrointestinal Hemorrhage.
Browse Gastrointestinal Hemorrhage studies →University Hospital Augsburg is the lead sponsor of 24 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
intraprocedural technical success
defined as reaching the descending duodenum and adequately assessing for the presence of a bleeding site
Time frame: Up to 20 minutes
intraprocedural clinical success
defined as successful endoscopic hemostasis during the examination if required
Time frame: Up to 45 Minutes
re-bleeding rate
need for further endoscopic, interventional-angiographic, or surgical intervention within 30 days due to upper GI-bleeding
Time frame: Up to 30 days
blood transfusions
Need for blood transfusion due to a hemorrhage-related decrease in hemoglobin levels ≤ 70 g/L
Time frame: Up to 30 days
Length of Stay
Duration of inpatient stay, measured from the day of admission to the day of discharge
Time frame: Up to 30 days
Length of intervention
measured from initiation to achievement of hemostasis
Time frame: 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
Time frame: Up to 60 Minutes
Adverse events
Occurrence of adverse events, such as perforation, bleeding exacerbation, aspiration, and infection.
Time frame: Up to 30 days
Plan to share: No
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University Hospital Augsburg