Comparing single-use and reusable gastroscopes in surgery
Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients
This study tests whether single-use gastroscopes work as well as reusable ones for patients needing a gastroscopy for upper gastrointestinal issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 700 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Zealand University Hospital Academic / other |
| Locations | 1 site (Køge) |
| Trial ID | NCT06581016 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the performance and technical outcomes of single-use gastroscopes compared to reusable gastroscopes in patients undergoing gastroscopy in the operating theater. Participants will first receive a gastroscopy using a single-use device, followed by a procedure with a reusable device to assess if their effectiveness and success rates are comparable. The study focuses on patients with upper gastrointestinal disorders who require gastroscopy, providing a direct comparison of these two types of instruments.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who require acute, subacute, or elective gastroscopies in the operating theater.
Not a fit: Patients who do not require gastroscopy or are under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved safety and efficiency in gastroscopy procedures, potentially influencing clinical practice.
How similar studies have performed: While there may be limited studies directly comparing single-use and reusable gastroscopes, the approach of evaluating performance characteristics is common in medical device assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Acute, subacute or elective gastroscopies in the operating theater * Age ≥ 18 years Exclusion Criteria: * None
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.