Bedside single-use gastroscopes versus reusable gastroscopes in the endoscopy unit for subacute inpatients
Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge) |
| Trial ID | NCT06771102 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Køge
- Zealand University Hospital — Køge, Denmark (Recruiting)
Study contacts
- Study coordinator: Camilla Kjelkvist-Born, MD
- Email: camkj@regionsjaelland.dk
- Phone: +4528263875
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.