Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

NCT ID: NCT03680950

Last Updated: 2020-06-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-12

Study Completion Date

2020-04-30

Brief Summary

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A monitoring system was developed for detecting upper gastrointestinal (UGI) rebleeding. This system consists of (1) a tiny endoscopy, (2) a wearable device, and (3) a software. The endoscopy is inserted to UGI tract via nasal cavity and then stayed there for 3 days. The wearable device is set to regularly receive the pictures from the endoscopy and sent to the software, which is able to automatically analyze whether the rebleeding occurs. This study aims to test the feasibility and efficacy of the monitoring system.

Detailed Description

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Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Upper Gastrointestinal Monitoring System

Participants who meet criteria of enrollment and is willing to join in this study will wear a real-time upper gastrointestinal monitoring system for checking whether upper gastrointestinal rebleeding occurs continuously for 3 days.

Group Type EXPERIMENTAL

Upper Gastrointestinal Monitoring System

Intervention Type DEVICE

Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.

Interventions

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Upper Gastrointestinal Monitoring System

Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* "Rockall" score ≧3

Exclusion Criteria

* Pregnant woman;
* Behavioral disorder;
* Major cognitive-perceptual deficit;
* The person who has a nasogastric (NG) tube;
* Other deficits or disorders that are not suitable for NG insertion;
* Participants who need to take MRI scan.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cheng-Kung University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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National Cheng Kung University Hospital

Tainan City, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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B-BR-106-096

Identifier Type: -

Identifier Source: org_study_id

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