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A Novel Portable Upper Gastrointestinal Endoscopy System

N

Naval Military Medical University

Status

Completed

Conditions

Diagnoses Disease
Digestive System Disease

Treatments

Device: a novel portable upper gastrointestinal endoscopy system

Study type

Interventional

Funder types

Other

Identifiers

NCT05211258
portable-endo

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

24 participants in 1 patient group

a novel portable upper gastrointestinal endoscopy system
Experimental group
Treatment:
Device: a novel portable upper gastrointestinal endoscopy system

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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