NCT05211258 - A Novel Portable Upper Gastrointestinal Endoscopy System | Crick

Overview

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 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 Type

INTERVENTIONAL

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

24

Conditions

Digestive System Disease Diagnoses Disease

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Changhai Hospital

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

The examination time

duration from the time the endoscope was inserted into the patient's mouth to the time it was withdrawn.

Time frame: 24 hours

Secondary Outcomes

adverse events

nausea, vomiting, throat discomfort, bleeding, etc

Time frame: one week

number of malfunctions of portable endoscopy system

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

Time frame: 24 hours