Risk Assessment of Indirect Exposure to the Environment in the Gastrointestinal Endoscopy Center
1 other identifier
interventional
100
1 country
1
Brief Summary
Study objective: To clarify the risk of exposure to indirect contact and transmission of environmental objects during digestive endoscopy diagnosis and treatment for patients and medical staff, simulating by using Vitamin B2 solution. Study design: This is a case-only research.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
April 11, 2022
CompletedStudy Start
First participant enrolled
July 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2025
CompletedNovember 29, 2023
November 1, 2023
2.2 years
March 16, 2022
November 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dosage of Indirect Contact Exposure of Environmental surfaces
A liquid of Vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the hands of every patient who is scheduled in the same endoscopy work unit (usually half a day) outside the endoscopy center. Then, the doctors and nurses conduct standard EGD procedure. After this endoscopy work unit is finished, the environmental surfaces touched by the patient are sampled by the wiping method. The dosage is detected by the Fluoro Max-4® fluorophotometer (HORIBA, Japan), which is quantified as a cumulative mass (μg) over all the exposure time.
one year
Study Arms (1)
Vitamin B2 labeled group
OTHERA liquid of vitamin B2 and hand sanitizer (0.12mg/mL) is marked on the patients' hands outside the endoscopy center.
Interventions
Using medical non-toxic fluorescent agents, VB2 solution, to mark the patient's hands before endoscopy examination.
Eligibility Criteria
You may qualify if:
- During the study period, patients who were treated in the digestive endoscopy center of Beijing Union Medical College Hospital and planned to undergo gastroscopy. Age and gender are not limited temporarily.
You may not qualify if:
- Allergic to medical non-toxic fluorescent agent: Vitamin B2 aqueous solution.
- Poor general condition, including severe cardiopulmonary disease, difficult to tolerate examination, and coagulation disorders.
- Patients with contraindications to endoscopy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peking Union Medical College Hospitallead
- Tsinghua Universitycollaborator
Study Sites (1)
Peking Union Medical College Hospital
Beijing, 100730, China
Study Officials
- STUDY DIRECTOR
Shengyu Zhang, MD
Peking Union Medical College Hospital
- PRINCIPAL INVESTIGATOR
Yuheng Zhang, MD candidate
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
March 16, 2022
First Posted
April 11, 2022
Study Start
July 1, 2022
Primary Completion
September 1, 2024
Study Completion
June 1, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11