NCT05211258

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 27, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 27, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

December 27, 2021

Last Update Submit

January 13, 2022

Conditions

Digestive System DiseaseDiagnoses Disease

Outcome Measures

Primary Outcomes (1)

  • The examination time

    duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.

    24 hours

Secondary Outcomes (2)

  • adverse events

    one week

  • number of malfunctions of portable endoscopy system

    24 hours

Study Arms (1)

a novel portable upper gastrointestinal endoscopy system

EXPERIMENTAL
Device: a novel portable upper gastrointestinal endoscopy system

Interventions

a novel portable upper gastrointestinal endoscopy systemDEVICE

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.

a novel portable upper gastrointestinal endoscopy system

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who underwent endoscopy examination with the portable system were aged from 18-70 years and presented with upper abdominal complaints.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Digestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 27, 2021

First Posted

January 27, 2022

Study Start

March 1, 2021

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

CN(1)