Upper Gastrointestinal DisorderNCT07727226
Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit
A study testing Ambu aScope Gastro and Reusable diagnostic gastroscopes (Olympus) in people with Upper Gastrointestinal Disorder, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Disorder
- What is being tested?
- Ambu aScope Gastro and Reusable diagnostic gastroscopes (Olympus)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- 27 Jul 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective or subacute gastroscopy in the endoscopy unit
- Age ≥ 18 years
Who cannot join
- Surveillance gastroscopy for Barrett's esophagus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Marie Louise Malmstrøm, MD, PhD contact
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Køge, 4600
Camilla Kjelkvist-Born, MD, +4528263875, camkj@regionsjaelland.dk
Marie Louise Malmstrøm, MD, PhD, malmstroem@gmail.com
About this study
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:
Read more
- 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.
- Conditions
- Upper Gastrointestinal Disorder
- Being tested
- Ambu aScope Gastro, Reusable diagnostic gastroscopes (Olympus)
- Keywords
- Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable
- Medical subject headings
- Gastrointestinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ambu aScope GastroDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Single-use gastroscope | Experimental | 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. Receives: Device: Ambu aScope Gastro |
| Reusable gastroscope | Active comparator | 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. Receives: Device: Reusable diagnostic gastroscopes (Olympus) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the gastroscopy procedure and completion of all procedure-related activities (same day).
Secondary outcomes (8)
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.
Measured: During the procedure
Cross-over rate
Frequency of gastroscopies requiring cross-over to another gastroscope
Measured: 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.
Measured: During the procedure
Complications
Complications related to gastroscopy
Measured: 24 hours and 72 hours follow-up after the procedure
30-day mortality
Mortality within 30 days after the procedure
Measured: 30 days after the procedure
Duration of procedure
The time from intubation with the gastroscope until removal of the gastroscope from the esophagus
Measured: 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.
Measured: 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.
Measured: After completion of the pathology examination (up to 2 months after the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start27 Jul 2026
- Primary completion30 Oct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal DisorderStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-inferiority quality assurance study comparing a period during which single-use gastroscopes are used with a period during which reusable gastroscopes are used.
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Camilla Kjelkvist-Born, Zealand University Hospital
- Investigators
- Lasse Bremholm Hansen, PhD,ass.prof, Study chair, Surgical department of Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07727226
- Sponsor's protocol ID
- SUSUES_endoscopyunit
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rommele C, Ayoub M, Scheppach MW, Muzalyova A, Wanzl J, Tadic V, Braun G, Weber T, Roser D, Nagl S, Messmann H, Ebigbo A. Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial. Endoscopy. 2026 May;58(5):481-490. doi: 10.1055/a-2735-1114. Epub 2025 Oct 29.
PubMed 41161323Weusten BLAM, Bisschops R, Dinis-Ribeiro M, di Pietro M, Pech O, Spaander MCW, Baldaque-Silva F, Barret M, Coron E, Fernandez-Esparrach G, Fitzgerald RC, Jansen M, Jovani M, Marques-de-Sa I, Rattan A, Tan WK, Verheij EPD, Zellenrath PA, Triantafyllou K, Pouw RE. Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2023 Dec;55(12):1124-1146. doi: 10.1055/a-2176-2440. Epub 2023 Oct 9.
PubMed 37813356Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17.
PubMed 35718068Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available.
PubMed 30772837Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9.
PubMed 35262904Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar.
PubMed 38504744Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30.
PubMed 32891225Rommele C, Ayoub M, Wanzl J, Tadic V, Braun G, Weber T, Scheppach MW, Roser D, Matic K, Nagl S, Messmann H, Ebigbo A. Clinical evaluation of a novel single-use therapeutic gastroscope: a pilot feasibility study. Endoscopy. 2025 Apr;57(4):339-344. doi: 10.1055/a-2436-7933. Epub 2024 Oct 8.
PubMed 39379048Han ZL, Lin BT, Wang ZJ, Chen X, Xi YY, Wang JF, Qiao WG, Huang Y, Lin ZZ, Huang SH, Chua TY, Liu SD, Luo XB. Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos). Dig Endosc. 2023 Nov;35(7):857-865. doi: 10.1111/den.14548. Epub 2023 Apr 5.
PubMed 36905288Ebigbo A, Tadic V, Schlottmann J, Braun G, Prinz F, Wanzl J, Ayoub M, Kraus L, Scheppach M, Nagl S, Schnoy E, Weber T, Probst A, Messmann H, Rommele C. Evaluation of a single-use gastroscope in patients presenting with suspected upper gastrointestinal hemorrhage: a pilot feasibility study (One-Scope I). Endoscopy. 2023 Oct;55(10):940-944. doi: 10.1055/a-2089-5969. Epub 2023 May 9.
PubMed 37160261van der Ploeg K, de Jonge PJF, Lammers WJ, Koch AD, Vos MC, Paulsen V, Aabakken L, Bruno M. Performance of a single-use gastroscope for esophagogastroduodenoscopy: Prospective evaluation. Endosc Int Open. 2024 Mar 18;12(3):E428-E434. doi: 10.1055/a-2271-2303. eCollection 2024 Mar.
PubMed 38504741Li DF, Shi RY, Tian YH, Xu ZL, Zhou YS, Sun XJ, Cai JW, Fang YY, Peng H, Wang JM, Dong T, Cai YD, Yao J, Wang LS. The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial. Z Gastroenterol. 2022 Sep;60(9):1314-1319. doi: 10.1055/a-1555-0568. Epub 2021 Nov 12.
PubMed 34768288Luo X, Ji M, Zhang S, Chen X, Zong Y, Zhang X, Hu H, Hao X, Shao L, Sun C, Shi H, Wang J, Wang B, Li P. Disposable versus reusable gastroscopes: a prospective randomized noninferiority trial. Gastrointest Endosc. 2022 Aug;96(2):250-261. doi: 10.1016/j.gie.2022.03.024. Epub 2022 Apr 4.
PubMed 35381230
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopists' Perspectives on the Use of Single-Use Gastroscopes in Elective and Subacute Patients in the Endoscopy Unit
- ClinicalTrials.gov ID
- NCT07727226
- Acronym / sponsor ID
- SUSUES_endoscopyunit
- Conditions
- Upper Gastrointestinal Disorder
- Keywords
- Gastroscopy, Upper endoscopy, Gastroscope, Single-use, Reusable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 27 Jul 2026 (actual)
- Primary completion
- 30 Oct 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-inferiority quality assurance study comparing a period during which single-use gastroscopes are used with a period during which reusable gastroscopes are used.
| Arm | Type | Receives |
|---|---|---|
| Single-use gastroscope | Experimental | Device: Ambu aScope GastroDuring 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. |
| Reusable gastroscope | Active comparator | Device: Reusable diagnostic gastroscopes (Olympus)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Elective or subacute gastroscopy in the endoscopy unit
- Age ≥ 18 years
Key exclusion criteria (1 listed)
- Surveillance gastroscopy for Barrett's esophagus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ambu aScope GastroCE-marked single-use gastroscopes from Ambu are used in the single-use group. | Device | Single-use gastroscope |
| Reusable diagnostic gastroscopes (Olympus)Reusable diagnostic gastroscopes from Olympus are used in the reusable group. | Device | Reusable gastroscope |
Primary outcome
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.
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.
8 secondary outcomes
Technical success of single-use gastroscopes vs reusable gastroscopes
Time frame: During the procedure
Cross-over rate
Time frame: During the procedure
Frequency of predefined endoscopic findings
Time frame: During the procedure
Complications
Time frame: 24 hours and 72 hours follow-up after the procedure
30-day mortality
Time frame: 30 days after the procedure
Duration of procedure
Time frame: During the procedure
Technical success rate of therapeutic endoscopic procedures
Time frame: During the procedure
Diagnostic adequacy rate of endoscopic biopsies
Time frame: After completion of the pathology examination (up to 2 months after the procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Background: PubMed 41161323Rommele C, Ayoub M, Scheppach MW, Muzalyova A, Wanzl J, Tadic V, Braun G, Weber T, Roser D, Nagl S, Messmann H, Ebigbo A. Single-use versus reusable gastroscopes for the initial assessment of patients with upper gastrointestinal bleeding: a prospective randomized noninferiority trial. Endoscopy. 2026 May;58(5):481-490. doi: 10.1055/a-2735-1114. Epub 2025 Oct 29.
- Background: PubMed 37813356Weusten BLAM, Bisschops R, Dinis-Ribeiro M, di Pietro M, Pech O, Spaander MCW, Baldaque-Silva F, Barret M, Coron E, Fernandez-Esparrach G, Fitzgerald RC, Jansen M, Jovani M, Marques-de-Sa I, Rattan A, Tan WK, Verheij EPD, Zellenrath PA, Triantafyllou K, Pouw RE. Diagnosis and management of Barrett esophagus: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2023 Dec;55(12):1124-1146. doi: 10.1055/a-2176-2440. Epub 2023 Oct 9.
- Background: PubMed 35718068Le NNT, Hernandez LV, Vakil N, Guda N, Patnode C, Jolliet O. Environmental and health outcomes of single-use versus reusable duodenoscopes. Gastrointest Endosc. 2022 Dec;96(6):1002-1008. doi: 10.1016/j.gie.2022.06.014. Epub 2022 Jun 17.
- Background: PubMed 30772837Bang JY, Sutton B, Hawes R, Varadarajulu S. Concept of disposable duodenoscope: at what cost? Gut. 2019 Nov;68(11):1915-1917. doi: 10.1136/gutjnl-2019-318227. Epub 2019 Feb 12. No abstract available.
- Background: PubMed 35262904Deb A, Perisetti A, Goyal H, Aloysius MM, Sachdeva S, Dahiya D, Sharma N, Thosani N. Gastrointestinal Endoscopy-Associated Infections: Update on an Emerging Issue. Dig Dis Sci. 2022 May;67(5):1718-1732. doi: 10.1007/s10620-022-07441-8. Epub 2022 Mar 9.
- Background: PubMed 38504744Cennamo V, Botter A, Landi S, Graziosi F, Bassi M, Dabizzi E, Ghersi S, Cerone G, Bonfiglioli R. Can single-use versus standard duodenoscope improve ergonomics in ERCP? A comparative, simulation-based pilot study. Endosc Int Open. 2024 Mar 18;12(3):E419-E427. doi: 10.1055/a-2231-7393. eCollection 2024 Mar.
- Background: PubMed 32891225Barakat MT, Banerjee S. Novel Algorithms for Reprocessing, Drying and Storing Endoscopes. Gastrointest Endosc Clin N Am. 2020 Oct;30(4):677-691. doi: 10.1016/j.giec.2020.06.003. Epub 2020 Jul 30.
- Background: PubMed 39379048Rommele C, Ayoub M, Wanzl J, Tadic V, Braun G, Weber T, Scheppach MW, Roser D, Matic K, Nagl S, Messmann H, Ebigbo A. Clinical evaluation of a novel single-use therapeutic gastroscope: a pilot feasibility study. Endoscopy. 2025 Apr;57(4):339-344. doi: 10.1055/a-2436-7933. Epub 2024 Oct 8.
- Background: PubMed 36905288Han ZL, Lin BT, Wang ZJ, Chen X, Xi YY, Wang JF, Qiao WG, Huang Y, Lin ZZ, Huang SH, Chua TY, Liu SD, Luo XB. Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos). Dig Endosc. 2023 Nov;35(7):857-865. doi: 10.1111/den.14548. Epub 2023 Apr 5.
- Background: PubMed 37160261Ebigbo A, Tadic V, Schlottmann J, Braun G, Prinz F, Wanzl J, Ayoub M, Kraus L, Scheppach M, Nagl S, Schnoy E, Weber T, Probst A, Messmann H, Rommele C. Evaluation of a single-use gastroscope in patients presenting with suspected upper gastrointestinal hemorrhage: a pilot feasibility study (One-Scope I). Endoscopy. 2023 Oct;55(10):940-944. doi: 10.1055/a-2089-5969. Epub 2023 May 9.
- Background: PubMed 38504741van der Ploeg K, de Jonge PJF, Lammers WJ, Koch AD, Vos MC, Paulsen V, Aabakken L, Bruno M. Performance of a single-use gastroscope for esophagogastroduodenoscopy: Prospective evaluation. Endosc Int Open. 2024 Mar 18;12(3):E428-E434. doi: 10.1055/a-2271-2303. eCollection 2024 Mar.
- Background: PubMed 34768288Li DF, Shi RY, Tian YH, Xu ZL, Zhou YS, Sun XJ, Cai JW, Fang YY, Peng H, Wang JM, Dong T, Cai YD, Yao J, Wang LS. The feasibility and safety of disposable endoscope vs. conventional endoscope for upper gastrointestinal tract examination: a multicenter, randomized, parallel, non-inferiority trial. Z Gastroenterol. 2022 Sep;60(9):1314-1319. doi: 10.1055/a-1555-0568. Epub 2021 Nov 12.
- Sealed Envelope Ltd. 2012. Power calculator for binary outcome non-inferiority trial. \[Accessed Wed Jul 01 2026\]Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie Louise Malmstrøm, MD, PhD contact
Lasse Bremholm Hansen, PhD,ass.prof study chair
Surgical department of Zealand University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ambu aScope Gastro and Reusable diagnostic gastroscopes (Olympus) in people with Upper Gastrointestinal Disorder, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Camilla Kjelkvist-Born, MD (+4528263875, camkj@regionsjaelland.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endoscopist-rated composite usability score (time frame: Procedure day (immediately after completion of the procedure)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07727226, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.