Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Denmark
Zealand University Hospital
RECRUITING
Køge
Contact Information
Primary
Camilla Kjelkvist-Born, MD
camkj@regionsjaelland.dk
+4528263875
Backup
Marie Louise Malmstrøm, MD, PhD
malmstroem@gmail.com
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2027-04
Participants
Target number of participants: 180
Treatments
Active_comparator: Reusable gastroscope in the endoscopy unit
In the first period the subacute gastroscopies will be performed with a reusable gastroscope in the endoscopy unit.
Experimental: Single-use gastroscope bedside in the patient's room
In the second period the subacute gastroscopies will be performed with a reusable gastroscope in bedside in the patients' rooms.
Related Therapeutic Areas
Sponsors
Leads: Zealand University Hospital