A Novel Portable Upper Gastrointestinal Endoscopy System

Diagnoses Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211258
• Other study ID #: portable-endo
• Status: Completed
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: January 2022
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diagnoses Disease
• Digestive System Disease
• Digestive System Diseases
• Gastrointestinal Diseases

Intervention

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.

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	adverse events	nausea, vomiting, throat discomfort, bleeding, etc	one week
Secondary	number of malfunctions of portable endoscopy system	hydropower and gas failure, image display failure, disposable sheathed system damage, etc.	24 hours