Comparing single-use and reusable gastroscopes for treating upper gastrointestinal bleeding
One-Scope II: Single-use Versus Reusable Gastroscopes in Patients With Upper Gastrointestinal Bleeding.
This study is testing whether single-use gastroscopes work better than reusable ones for treating patients with upper gastrointestinal bleeding.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital Augsburg Academic / other |
| Locations | 1 site (Augsburg, Bavaria) |
| Trial ID | NCT06192355 on ClinicalTrials.gov |
What this trial studies
This trial evaluates the effectiveness of single-use gastroscopes compared to reusable ones in patients experiencing upper gastrointestinal bleeding, a common medical emergency. The study is a controlled-randomized trial that aims to assess the impact of these two types of gastroscopes on patient outcomes and cost-effectiveness. Given the urgency of endoscopic evaluation within 24 hours of bleeding onset, the trial seeks to address hygiene concerns and the feasibility of using single-use devices in emergency settings. The findings from this study could provide valuable insights into improving endoscopic procedures for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with a Glasgow-Blatchford score greater than 2 and clinical signs of upper gastrointestinal bleeding.
Not a fit: Patients who are pregnant or unable to provide consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance patient outcomes by determining the most effective and hygienic method for endoscopic intervention in upper gastrointestinal bleeding.
How similar studies have performed: Previous studies have shown the feasibility of using single-use gastroscopes, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Glasgow-Blatchford score (GBS) \>2 * Clinical signs of upper bleeding Exclusion Criteria: * pregnancy * Unable to provide consent
Where this trial is running
Augsburg, Bavaria
- University Hospital of Augsburg — Augsburg, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Christoph Römmele, MD — Unervsity Hospital Augsburg
- Study coordinator: Christoph Römmele, MD
- Email: christoph.roemmele@uk-augsburg.de
- Phone: +498214002351
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.