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NCT Number: NCT07727226

Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit

The aim of this clinical trial is to investigate whether single-use gastroscopes perform comparably to reusable gastroscopes when used in an endoscopy unit during a period of reduced endoscope reprocessing capacity.

The main question the study aims to answer is:

- How do endoscopists evaluate the performance of single-use gastroscopes compared with reusable gastroscopes in elective and subacute patients undergoing gastroscopy in the endoscopy unit?

Researchers will compare single-use and reusable gastroscopes to determine whether they provide comparable clinical performance. In addition, the study will evaluate the economic consequences of temporarily implementing single-use gastroscopes during a period of reduced reprocessing capacity, as well as compare selected clinical outcomes, including technical success, procedural complications, and the frequency of endoscopic findings.

Participants undergoing gastroscopy during the first study period will be examined using a single-use gastroscope. Participants undergoing gastroscopy during the second study period will be examined using a reusable gastroscope.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective or subacute gastroscopy in the endoscopy unit
  • Age ≥ 18 years

Exclusion criteria

  • Surveillance gastroscopy for Barrett's esophagus

Treatment and study plan

Ambu aScope Gastro

Device

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

Reusable diagnostic gastroscopes (Olympus)

Device

Reusable diagnostic gastroscopes from Olympus are used in the reusable group.

Primary outcomes

  1. Endoscopist-rated composite usability score

    Time frame: Procedure day (immediately after completion of the procedure)

    Comparison of the composite endoscopist-rated performance score of single-use and reusable gastroscopes. The composite score will be calculated as the mean of all items rated on a 5-point Likert-scale questionnaire.

  2. Cost per gastroscopy during the single-use period compared with the reusable period

    Time frame: During the gastroscopy procedure and completion of all procedure-related activities (same day).

    Cost per gastroscopy (EUR) will be calculated for each study period using hospital administrative and procedural data. The calculation will include:

    • Diagnosis-Related Group (DRG) reimbursement value for gastroscopy
    • Purchase cost of the single-use gastroscope
    • Reprocessing cost of reusable gastroscopes
    • Staff time required for preparation and post-procedure work for each gastroscope type
    • Additional hospital costs associated with transferring patients to other hospitals or private providers due to reduced endoscope reprocessing capacity.

Secondary outcomes

  1. Technical success of single-use gastroscopes vs reusable gastroscopes

    Time frame: During the procedure

    Technical success will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Technical success is defined as successful advancement of the gastroscope to the second part of the duodenum and the ability to identify or exclude the suspected diagnosis. In procedures with an impassable stenosis or tumor, technical success is defined as successful identification of the lesion and obtaining biopsies sufficient for diagnostic evaluation when clinically indicated. The outcome will be reported as the proportion of procedures meeting the predefined criteria for technical success.

  2. Cross-over rate

    Time frame: During the procedure

    Frequency of gastroscopies requiring cross-over to another gastroscope

  3. Frequency of predefined endoscopic findings

    Time frame: During the procedure

    Endoscopic findings will be determined by retrospective review of the endoscopy report using predefined study categories. The frequency of each predefined endoscopic finding will be compared between the single-use and reusable gastroscope groups.

  4. Complications

    Time frame: 24 hours and 72 hours follow-up after the procedure

    Complications related to gastroscopy

  5. 30-day mortality

    Time frame: 30 days after the procedure

    Mortality within 30 days after the procedure

  6. Duration of procedure

    Time frame: During the procedure

    The time from intubation with the gastroscope until removal of the gastroscope from the esophagus

  7. Technical success rate of therapeutic endoscopic procedures

    Time frame: During the procedure

    Technical success of therapeutic endoscopic procedures will be determined by retrospective review of the endoscopy report and medical record using predefined study criteria. Therapeutic procedures include, but are not limited to, endoscopic hemostasis of bleeding ulcers, variceal band ligation, stent placement, foreign body removal, and dilation. Success is defined as successful completion of the intended therapeutic intervention according to the predefined criteria for each procedure (e.g., successful hemostasis, successful band ligation, successful stent deployment, or successful removal of foreign bodies). The outcome will be reported as the proportion of therapeutic procedures meeting the predefined criteria for technical success and compared between the single-use and reusable gastroscope groups.

  8. Diagnostic adequacy rate of endoscopic biopsies

    Time frame: After completion of the pathology examination (up to 2 months after the procedure)

    Diagnostic adequacy of endoscopic biopsies will be determined by retrospective review of the pathology report and endoscopy report using predefined study criteria. A biopsy will be considered adequate if the pathological examination provides sufficient information to either establish or exclude the suspected diagnosis. The outcome will be reported as the proportion of biopsies considered diagnostically adequate among procedures where biopsies were obtained and compared between the single-use and reusable gastroscope groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Camilla Kjelkvist-Born, MD

CONTACT

[email protected]

+4528263875

Marie Louise Malmstrøm, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2026
Registry last updated
Jul 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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