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Completed

NCT Number: NCT03680950

Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System

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.

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Key information

Conditions

Upper Gastrointestinal Bleeding Digestive System Diseases Gastrointestinal Diseases Gastrointestinal Hemorrhage Hemorrhage Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Upper Gastrointestinal Monitoring System

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.

Primary outcomes

  1. Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.

    Time frame: 3 days

    The real-time upper gastrointestinal monitoring system is compared with the current monitoring index. The efficacy is estimated by which monitoring method finding the upper gastrointestinal rebleeding first.

Secondary outcomes

  1. The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.

    Time frame: 3 days

    The accuracy of the current monitoring index and the real-time upper gastrointestinal monitoring system is compared. The accuracy is estimated by calculating the ratio of the number of making false alarm and the number of finding re-bleeding right.

Sponsors and collaborators

Lead sponsor

National Cheng-Kung University Hospital

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 21, 2018
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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