Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus… (NCT06771102) | Clinical Trial Compass
RecruitingNot Applicable
Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
Denmark180 participantsStarted 2025-01-13
Plain-language summary
The aim of this study is to investigate whether single-use gastroscopes used bedside can reduce the time from indication to procedure compared with re-usable gastroscopes used at the endoscopy unit in patients referred to a subacute gastroscopy.
Participants in the first period will be scheduled for gastroscopy with a re-usable gastroscope in the endoscopy unit, whereas participants during the second period will have a gastroscopy performed at the ward (bed-side) with a single-use gastroscope.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time from the indication/decision for early endoscopy to procedure
Timeframe: From indication to procedure, up to two weeks