Diagnoses Disease, Digestive System Disease
Conditions
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.
Interventions
DEVICEa 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.
Sponsors
Changhai Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed