An interventional study of Ambu aScope Gastro and Reusable diagnostic gastroscopes (Olympus) in Upper Gastrointestinal Disorder, sponsored by Zealand University Hospital. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Zealand University Hospital · Not applicable, Interventional, and Diagnostic
Among 21 studies in Gastrointestinal Diseases with a site in Denmark — 6 open to participants now, 10 under way, 3 of them phase 3. Gastrointestinal Diseases · Denmark.
Among the 21 studies in Gastrointestinal Diseases with a site in Denmark, this one is the 6th largest by planned enrollment of the 17 interventional ones that give a count, is one of 2 that started in 2026, is one of 8 with no phase, and was the 21st registered.
548 studies on the registry are indexed under Gastrointestinal Diseases; 101 are open to participants now.
Browse Gastrointestinal Diseases studies →6 of the 21 studies in Gastrointestinal Diseases with a site in Denmark are open now. Recruiting first, the newest first:
Zealand Pharma · Sites in Denmark, United States, Austria and 11 more countries
Ages 18–90
Pfizer · Sites in Denmark, United States, Argentina and 14 more countries
Ages 18+
Zealand University Hospital · Sites in Denmark
Ages 18+
Zealand University Hospital · Sites in Denmark
Ages 18+
Turning Point Therapeutics, Inc. · Sites in Denmark, United States, Australia and 16 more countries
Ages 12+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 65 Gastrointestinal Diseases studies recruiting now, 30 (46%) set no upper age limit and 22 (34%) stop at 75 or younger; 18 take children under 18; 20 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
21 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 4 · Phase 3 6
First in 1999; this study’s year is marked. 2 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 300 is above the median of 80 across 388 interventional studies indexed under Gastrointestinal Diseases.
Median enrollment 143 across the 17 interventional studies, 773 across the 4 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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10 of 21 have an industry lead sponsor. The 10 most frequent:
Zealand University Hospital is the lead sponsor of 236 studies on the registry; 50 are open to participants now.
Zealand University Hospital has 5 studies filed under Gastrointestinal Diseases — fewer than ten, so there is no comparison to draw.
2 of the studies in Gastrointestinal Diseases with a site in Denmark that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06771102Zealand University HospitalPerformance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients | 2027-01 |
| NCT07727226Zealand University HospitalEndoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit | 2027-10-30 |
Add all 2 to your calendar (.ics) → With an account.
Among the 21 studies in Gastrointestinal Diseases with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
During the first study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using single-use gastroscopes.
Device: Ambu aScope Gastro
During the second study period, all gastroscopies performed in the endoscopy unit between 11:00 and 15:00 will be carried out using reusable gastroscopes.
Device: Reusable diagnostic gastroscopes (Olympus)
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.
Endoscopist-rated composite usability score
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: Procedure day (immediately after completion of the procedure)
Cost per gastroscopy during the single-use period compared with the reusable period
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.
Time frame: During the gastroscopy procedure and completion of all procedure-related activities (same day).
Technical success of single-use gastroscopes vs reusable gastroscopes
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
Cross-over rate
Frequency of gastroscopies requiring cross-over to another gastroscope
Time frame: During the procedure
Frequency of predefined endoscopic findings
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: During the procedure
Complications
Complications related to gastroscopy
Time frame: 24 hours and 72 hours follow-up after the procedure
30-day mortality
Mortality within 30 days after the procedure
Time frame: 30 days after the procedure
Duration of procedure
The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
Time frame: During the procedure
Technical success rate of therapeutic endoscopic procedures
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: During the procedure
Diagnostic adequacy rate of endoscopic biopsies
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.
Time frame: After completion of the pathology examination (up to 2 months after the procedure)
Plan to share: No
Started Jul 2026 (actual). Primary completion is estimated for Oct 2027, 15 months after the start.
Of 127 non-industry interventional studies with no phase under Gastrointestinal Diseases, half reached primary completion within 26 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 15 months is below that.
Counting every sponsor, half of 149 studies reached it within 24 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
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