Bedside single-use gastroscopes versus reusable gastroscopes in the endoscopy unit for subacute inpatients
Official title: Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
Run by Zealand University Hospital · NCT06771102 · Data updated 2026-11-12
This test will see if using single-use gastroscopes at the bedside shortens the time from referral to gastroscopy compared with sending hospitalized adults to the endoscopy unit with reusable scopes.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 180 (estimated) |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge) |
| Status | Recruiting |
| Started | January 13, 2025 |
| Main results expected | January 2027 |
| Study ends | April 2027 |
| Registry record updated | July 16, 2026 |
| Trial ID | NCT06771102 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) admitted to the acute surgical ward at Zealand University Hospital who are referred for early gastroscopy without general anesthesia and who are hemodynamically stable with ASA score <4 are ideal candidates.
✕Probably not a fit
Patients who are unstable, have an ASA score of 4 or higher, suspected active bleeding or ventricular retention, require expert endoscopist interventions (e.g., stenting), or are under 18 are unlikely to benefit from this bedside approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a two-period comparison in adults admitted to the acute surgical ward at Zealand University Hospital referred for early upper endoscopy without general anesthesia. In the first period participants undergo gastroscopy in the endoscopy unit using reusable Olympus gastroscopes, and in the second period procedures are done at the bedside using single-use Ambu aScope Gastro devices. The primary outcome is the time from indication/referral to completion of the procedure, with secondary technical and workflow outcomes recorded. The trial excludes unstable patients, those with high ASA scores, active bleeding, suspected gastric outlet obstruction, or cases needing an expert endoscopist.
Why it matters
Potential benefit: If successful, bedside single-use gastroscopes could reduce waiting time for gastroscopy, speed diagnosis and treatment, and avoid transporting patients to the endoscopy unit.
How similar studies have gone: Previous work has shown single-use endoscopes are feasible and can reduce infection risk, but evidence that they reliably shorten time-to-procedure in subacute inpatient settings is limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients of any gender, 18 years of age or older admitted to the acute section of the surgical department (Kir2) at Zealand University Hospital referred to early EGD without general anesthesia. Exclusion Criteria: * ASA-score of 4 or higher * Unstable patient * Suspicion of ventricular retention * Suspicion of active bleeders * Need for expert endoscopist to perform the procedure, e.g. stenting * Patients \< 18 years of age
Where it's running
-
Zealand University Hospital
Køge, Denmark Recruiting
Study contacts
- Study coordinator: Camilla Kjelkvist-Born, MD
- Email: camkj@regionsjaelland.dk
- Phone: +4528263875
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.