Upper Gastrointestinal Disorder
Conditions
Keywords
Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable
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.
Interventions
DEVICEAmbu aScope Gastro
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
DEVICEAmbu aScope Gastro Large
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable gastroscopes from Olympus are used in the reusable group.
DEVICETherapeutic gastroscopes, Olympus
Reusable gastroscopes from Olympus are used in the reusable group.
Sponsors
University Hospital, Umeå
Zealand University Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Acute, subacute or elective gastroscopies in the operating theater * Age ≥ 18 years
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical success of single-use gastroscopes vs reusable gastroscopes | From admission to discharge, up to 3 months | Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30th day mortality | 30 days | Mortality after 30 days after procedure |
| Endoscopist's rating of gastroscope | Right after procedure | The endoscopist's rating of the gastroscope |
| Duration of procedure | During the procedure | The time from intubation of gastroscope until gastroscope removed from esophagus. |
| Time from procedure to discharge | From procedure to discharge, up to 3 months | Time from procedure to discharge |
| Complications | 24 hours and 72 hours follow-up after procedure | Complications to gastroscopy |
| Need of new gastroscopy | During admission, up to 3 months | Need of new gastroscopy during admission |
| Readmission | 30 days after procedure | Does the patient need readmission after discharge |
| Sufficient ability to target the biopsy if taken | During procedure | Successful biopsy which the pathologist can use to either diagnose the patient or to reject a diagnose. |
| Success of specific therapeutic procedures | During the procedure | E.g. success in treating ulcers, banding or stenting |
Countries
Denmark
Contacts
Primary ContactCamilla Kjelkvist-Born, MD
Backup ContactMarie Louise Malmstrøm, MD, PhD
Outcome results
None listed