Evaluation of a novel disposable esophagogastroduodenoscopy system in emergency, bedside, and intraoperative settings: Pilot study (with videos).
Ze-Long Han, Bi-Tao Lin, Zhen-Jiang Wang...
https://pubmed.ncbi.nlm.nih.gov/36905288/Actively Recruiting
Led by Zealand University Hospital · Updated on 2026-07-16
180
Participants Needed
1
Research Sites
12 weeks
Total Duration
This research aims to compare the use of single-use gastroscopes performed bedside with reusable gastroscopes used in the endoscopy unit for patients needing subacute gastroscopy. The study focuses on whether bedside single-use devices can reduce the time from the decision to perform the procedure until it happens. It involves patients admitted to the acute surgical department who require early gastroscopy without general anesthesia. Participants will be divided into two groups based on the time period of the study. In the first period, gastroscopies will be done with reusable gastroscopes at the endoscopy unit. In the second period, gastroscopies will be performed bedside in the patients rooms using single-use CE-marked Ambu aScope Gastro devices. The study compares these two approaches regarding procedure timing and technical outcomes. During the study, researchers will track the time from indication to procedure and discharge, procedure duration, sedation use, and technical success. They will also monitor complications, mortality, readmissions, need for repeat gastroscopy, and endoscopists ratings of the devices. Nurse learning curves during the second period will be assessed. Follow-up includes up to 3 months post-procedure monitoring and a 30-day mortality check. This allows comprehensive evaluation of the devices performance and patient outcomes.
CONDITIONS
Performance Characteristics and Technical Outcomes of Single-use Gastroscopes Used Bedside Versus Reusable Gastroscopes Used in the Endoscopy Unit Evaluated in Subacute Patients
C
Camilla Kjelkvist-Born, MD
M
Marie Louise Malmstrøm, MD, PhD
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Zealand University Hospital
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 weeks from indication to procedure
Participants undergo gastroscopy either with reusable gastroscopes in the endoscopy unit or with single-use gastroscopes bedside in their rooms, depending on the study period.
1 procedure visit
Duration - Up to 3 months
Researchers monitor participants for up to 3 months after the procedure to assess discharge timing, complications, readmissions, and mortality.
Follow-up visits or contacts as needed
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Lead Sponsor