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Completed

NCT Number: NCT05211258

A Novel Portable Upper Gastrointestinal Endoscopy System

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.

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Key information

Conditions

Digestive System Disease Diagnoses Disease Digestive System Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

a novel portable upper gastrointestinal endoscopy system

Device

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 outcomes

  1. The examination time

    Time frame: 24 hours

    duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.

Secondary outcomes

  1. adverse events

    Time frame: one week

    nausea, vomiting, throat discomfort, bleeding, etc

  2. number of malfunctions of portable endoscopy system

    Time frame: 24 hours

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

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Registry information

Official study title

A Novel Portable Upper Gastrointestinal Endoscopy System Applied in Remote Populations: A Pilot Study

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 27, 2022
Registry last updated
Jan 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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