Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
1 other identifier
interventional
18
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 21, 2018
CompletedStudy Start
First participant enrolled
October 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedJune 16, 2020
May 1, 2020
1.4 years
September 17, 2018
June 14, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.
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.
3 days
Secondary Outcomes (1)
The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.
3 days
Study Arms (1)
Upper Gastrointestinal Monitoring System
EXPERIMENTALParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- "Rockall" score ≧3
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Cheng Kung University Hospital
Tainan, 704, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 17, 2018
First Posted
September 21, 2018
Study Start
October 12, 2018
Primary Completion
March 12, 2020
Study Completion
April 30, 2020
Last Updated
June 16, 2020
Record last verified: 2020-05