A Novel Portable Upper Gastrointestinal Endoscopy System

Sponsor
Changhai Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05211258
Collaborator
(none)
24
1
1
4
6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: a novel portable upper gastrointestinal endoscopy system
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
A Novel Portable Upper Gastrointestinal Endoscopy System Applied in Remote Populations: A Pilot Study
Actual Study Start Date :
Mar 1, 2021
Actual Primary Completion Date :
Jun 30, 2021
Actual Study Completion Date :
Jun 30, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: a novel portable upper gastrointestinal endoscopy system

Device: a novel portable upper gastrointestinal endoscopy system
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.

Outcome Measures

Primary Outcome Measures

  1. The examination time [24 hours]

    duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.

Secondary Outcome Measures

  1. adverse events [one week]

    nausea, vomiting, throat discomfort, bleeding, etc

  2. number of malfunctions of portable endoscopy system [24 hours]

    hydropower and gas failure, image display failure, disposable sheathed system damage, etc.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Changhai Hospital Shanghai Shanghai China 200433

Sponsors and Collaborators

  • Changhai Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zhuan Liao, Professor, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT05211258
Other Study ID Numbers:
  • portable-endo
First Posted:
Jan 27, 2022
Last Update Posted:
Jan 27, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 27, 2022