Disposable endoscopic biopsy forceps: comparison with standard forceps of sample size and adequacy of specimen.
D J Turk, R A Kozarek, V A Botoman...
https://pubmed.ncbi.nlm.nih.gov/2007750Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID06581016
Performance Characteristics and Technical Outcomes of Single-use Versus Reusable Gastroscopes Evaluated in the Operating Room in Acute, Subacute and Elective Patients
Led by Zealand University Hospital · Updated on 2026-01-09
700
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
Z
Zealand University Hospital
Lead Sponsor
U
University Hospital, Umeå
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating whether single-use gastroscopes perform as well as reusable gastroscopes during gastroscopy procedures conducted in the operating theater. The study aims to determine if the technical success and performance characteristics of single-use devices match those of reusable ones across patients who need gastroscopy in this setting. Participants will first undergo gastroscopy using single-use gastroscopes, specifically the CE-marked Ambu aScope Gastro and Ambu aScope Gastro Large devices. In a subsequent period, gastroscopies will be performed using reusable gastroscopes from Olympus, including both diagnostic and therapeutic models. This comparison spans acute, subacute, and elective patients undergoing procedures in the operating room. Throughout the study, researchers will assess technical success from admission until discharge, with follow-up up to three months. They will also monitor complications at 24 and 72 hours post-procedure, mortality at 30 days, procedure duration, endoscopist satisfaction, and the need for additional gastroscopies or readmission. Biopsy targeting success and time from procedure to discharge will also be evaluated to understand the overall performance and outcomes associated with each gastroscope type.
CONDITIONS
Brief Title
Performance Characteristics and Technical Outcomes of Single-use vs. Reusable Gastroscopes Evaluated in the OR
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Acute, subacute or elective gastroscopies in the operating theater
- Age 65 18 years
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Implementation
Duration - From procedure until discharge, up to 3 months
Participants undergo gastroscopy using either single-use or reusable gastroscopes in the operating room.
1 procedure visit and up to 3 months follow-up
Follow-up
Duration - Up to 3 months after procedure
Participants are monitored for complications and recovery after the gastroscopy procedure.
Visits at 24 hours, 72 hours, and 30 days after procedure
Trial Site Locations
Total: 1 location
1
Zealand University Hospital
Køge, Denmark, 4600
Actively Recruiting
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Research Team
C
Camilla Kjelkvist-Born, MD
M
Marie Louise Malmstrøm, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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