Zealand University Hospital
Køge, 4600, Denmark
Location status: Recruiting
Location contact
Camilla Kjelkvist-Born, MD
CONTACT
Marie Louise Malmstrøm, MD, PhD
CONTACT
NCT Number: NCT07727226
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Køge, 4600, Denmark
Location status: Recruiting
Camilla Kjelkvist-Born, MD
CONTACT
Marie Louise Malmstrøm, MD, PhD
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
CE-marked single-use gastroscopes from Ambu are used in the single-use group.
Reusable diagnostic gastroscopes from Olympus are used in the reusable group.
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.
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:
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.
Time frame: During the procedure
Frequency of gastroscopies requiring cross-over to another gastroscope
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.
Time frame: 24 hours and 72 hours follow-up after the procedure
Complications related to gastroscopy
Time frame: 30 days after the procedure
Mortality within 30 days after the procedure
Time frame: During the procedure
The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
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.
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.
Contact information is provided by the study sponsor or research team.
Camilla Kjelkvist-Born, MD
CONTACT
Marie Louise Malmstrøm, MD, PhD
CONTACT
Zealand University Hospital
Other
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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