A Novel Portable Upper Gastrointestinal Endoscopy System

Not Applicable

Completed

• Conditions: Digestive System Disease; Diagnoses Disease
• Interventions: Device: a novel portable upper gastrointestinal endoscopy system

• Registration Number: NCT05211258
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2021-03-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-06-30
• Study First Submitted: 2021-12-27
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-13
• Last Update Submitted: 2022-01-13
• Study First Posted: 2022-01-27
• Last Update Posted: 2022-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
a novel portable upper gastrointestinal endoscopy system	a novel portable upper gastrointestinal endoscopy system	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
adverse events	one week	nausea, vomiting, throat discomfort, bleeding, etc
number of malfunctions of portable endoscopy system	24 hours	hydropower and gas failure, image display failure, disposable sheathed system damage, etc.

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China