Back to resultsEfficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Upper Gastrointestinal Monitoring System
Sponsored by
About this trial
This is an interventional diagnostic trial for Upper Gastrointestinal Bleeding
Eligibility Criteria
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.
Sites / Locations
- National Cheng Kung University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Upper Gastrointestinal Monitoring System
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.
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.
Full Information
NCT ID
NCT03680950
First Posted
September 17, 2018
Last Updated
June 14, 2020
Sponsor
National Cheng-Kung University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03680950
Brief Title
Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Official Title
Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cheng-Kung University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Upper Gastrointestinal Monitoring System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Upper Gastrointestinal Monitoring System
Intervention Description
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 Outcome Measure Information:
Title
Time to detection of upper gastrointestinal rebleeding between the upper gastrointestinal monitoring system vs. the current monitoring index.
Description
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.
Time Frame
3 days
Secondary Outcome Measure Information:
Title
The accuracy of upper gastrointestinal rebleeding detection between the upper gastrointestinal monitoring system vs. the current monitoring index.
Description
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.
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
National Cheng Kung University Hospital
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Efficacy Test of Real-Time Upper Gastrointestinal Monitoring System
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