Back to resultsA Novel Portable Upper Gastrointestinal Endoscopy System
Primary Purpose
Digestive System Disease, Diagnoses Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
a novel portable upper gastrointestinal endoscopy system
Sponsored by
About this trial
This is an interventional diagnostic trial for Digestive System Disease
Eligibility Criteria
Inclusion Criteria:
- Patients who underwent endoscopy examination with the portable system were aged from 18-70 years and presented with upper abdominal complaints.
Exclusion Criteria:
- The exclusion criteria were the same as the contraindications for conventional upper GI endoscopy and included latex allergy
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
a novel portable upper gastrointestinal endoscopy system
Arm Description
Outcomes
Primary Outcome Measures
The examination time
duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.
Secondary Outcome Measures
adverse events
nausea, vomiting, throat discomfort, bleeding, etc
number of malfunctions of portable endoscopy system
hydropower and gas failure, image display failure, disposable sheathed system damage, etc.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05211258
Brief Title
A Novel Portable Upper Gastrointestinal Endoscopy System
Official Title
A Novel Portable Upper Gastrointestinal Endoscopy System Applied in Remote Populations: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The application of conventional endoscopy in remote and outdoor areas lacking facilities remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal endoscopy system that has the same functions as conventional endoscopy. A total of 24 participants from a medical unit on a remote island in China underwent endoscopy with the portable system between March and June 2021. The portable system packed into a suitcase is 68 × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system.
Detailed Description
The application of conventional endoscopy in remote and outdoor areas lacking facilities remains challenges. Thus, the investigators developed a novel portable upper gastrointestinal endoscopy system that has the same functions as conventional endoscopy. A total of 24 participants from a medical unit on a remote island in China underwent endoscopy with the portable system between March and June 2021. The portable system packed into a suitcase is 68 × 42 × 32 cm in size, weighing less than 35 kg, and comprises a disposable sheathed system. The examination time and any malfunctions in the portable endoscopy system during the examination were recorded. After the examination was finished, the disposable sheathed system was removed, and a pressure leak test was performed to check the seal of the system. The patients were followed up within three days to confirm any adverse events such as nausea, vomiting, throat discomfort, bleeding, etc.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Digestive System Disease, Diagnoses Disease
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a novel portable upper gastrointestinal endoscopy system
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
a novel portable upper gastrointestinal endoscopy system
Intervention Description
Patients arrived at the hospital in the morning after an overnight fast (>6 hours). The patients took oral dyclonine glue 15 mins before their examination. The doctors prepared the portable endoscopy system so that it was in working status and the disposable sheathed system was placed on the endoscope optical probe.
Primary Outcome Measure Information:
Title
The examination time
Description
duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
adverse events
Description
nausea, vomiting, throat discomfort, bleeding, etc
Time Frame
one week
Title
number of malfunctions of portable endoscopy system
Description
hydropower and gas failure, image display failure, disposable sheathed system damage, etc.
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients who underwent endoscopy examination with the portable system were aged from 18-70 years and presented with upper abdominal complaints.
Exclusion Criteria:
The exclusion criteria were the same as the contraindications for conventional upper GI endoscopy and included latex allergy
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
A Novel Portable Upper Gastrointestinal Endoscopy System
We'll reach out to this number within 24 hrs