Health TrialsbyHealthPanel

Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR

ConditionUpper Gastrointestinal Disorder
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorZealand University Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Acute, subacute or elective gastroscopies in the operating theater

Age ≥ 18 years

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ambu aScope Gastro

    Device

    CE-marked single-use gastroscopes from Ambu are used in the single-use group.

  • Ambu aScope Gastro Large

    Device

    CE-marked single-use gastroscopes from Ambu are used in the single-use group.

  • Diagnostic gastroscopes, Olympus

    Device

    Reusable gastroscopes from Olympus are used in the reusable group.

  • Therapeutic gastroscopes, Olympus

    Device

    Reusable gastroscopes from Olympus are used in the reusable group.

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Single-use gastroscopeExperimental treatment 2 interventions
Group B: Reusable gastroscopeActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Technical success of single-use gastroscopes vs reusable gastroscopes

Technical success is defined as the ability to complete the procedure adequately based on the indication and guidelines.

Time frame
From admission to discharge, up to 3 months

Secondary outcomes

1

Complications

Complications to gastroscopy

Time frame
24 hours and 72 hours follow-up after procedure
2

30th day mortality

Mortality after 30 days after procedure

Time frame
30 days
3

Endoscopist's rating of gastroscope

The endoscopist's rating of the gastroscope

Time frame
Right after procedure
4

Duration of procedure

The time from intubation of gastroscope until gastroscope removed from esophagus.

Time frame
During the procedure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zealand University Hospital

Lead sponsor

University Hospital, Umeå

Collaborator

Source ClinicalTrials.gov
Apply now