A Novel Portable Upper Gastrointestinal Endoscopy System

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Digestive System Disease, Diagnoses Disease

Intervention / Treatment
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* Device: a novel portable upper gastrointestinal endoscopy system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: a novel portable upper gastrointestinal endoscopy system<br> | Device: a novel portable upper gastrointestinal endoscopy system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse events | nausea, vomiting, throat discomfort, bleeding, etc | one week | 
| number of malfunctions of portable endoscopy system | hydropower and gas failure, image display failure, disposable sheathed system damage, etc. | 24 hours |