Clinical trial NCT06581016: Performance Characteristics and Technical Outcomes of Single-use Vs. Reusable Gastroscopes Evaluated in the or
Official title: Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Upper Gastrointestinal Disorder
Keywords: Gastroscopy
Upper endoscopy
Gastroscope
Single-use
Reusable
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Umeå
First posted: 2024-08-30
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Non-inferiority, quality assurance study comparing a period where single-use gastroscopes are used with a period where reusable gastroscopes are used.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate whether single-use gastroscopes are as good as reusable gastroscopes when used in the operation theater in all patients where gastroscopy in the operation theater is indicated. The main question it aims to answer is:

- Is the technical success and performance characteristics the same for single-use and reusable gastroscopies?

Researchers will compare single-use gastroscopes with reusable gastroscopes to see if the technical success and performance characteristics are the same in the to groups.

Participants will in the first period have gastroscopy with a single-use gastroscope. In the second period participants will have gastroscopy with a reusable gastroscope.


Eligibility criteria: Inclusion Criteria:

* Acute, subacute or elective gastroscopies in the operating theater
* Age ≥ 18 years

Exclusion Criteria:

* None

Primary outcomes:
measure: Technical success of single-use gastroscopes vs reusable gastroscopes
timeFrame: From admission to discharge, up to 3 months
Secondary outcomes:
measure: Complications
timeFrame: 24 hours and 72 hours follow-up after procedure
measure: 30th day mortality
timeFrame: 30 days
measure: Endoscopist's rating of gastroscope
timeFrame: Right after procedure
measure: Duration of procedure
timeFrame: During the procedure
measure: Time from procedure to discharge
timeFrame: From procedure to discharge, up to 3 months
measure: Success of specific therapeutic procedures
timeFrame: During the procedure
measure: Need of new gastroscopy
timeFrame: During admission, up to 3 months
measure: Readmission
timeFrame: 30 days after procedure
measure: Sufficient ability to target the biopsy if taken
timeFrame: During procedure
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
affiliation: Surgical department of Zealand University Hospital
name: Lasse Bremholm Hansen, PhD,ass.prof
role: STUDY_CHAIR
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