A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of Upper Gastrointestinal Bleeding
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and oesophago-gastro-duodenoscopy (OGD).
Eligibility
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
⁃ Subjects are eligible if:
• They have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, history of hematemesis);
• They will undergo OGD within 24 hours;
• Written consent obtained.
Locations
Other Locations
Hong Kong Special Administrative Region
Prince of Wales Hospital
RECRUITING
Hong Kong
Contact Information
Primary
Felix Sia
felixsia@cuhk.edu.hk
26370428
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2025-05-30
Participants
Target number of participants: 30
Treatments
Experimental: Hemopill
HemoPill® acute capsule (Ovesco Endoscopy, Tuebingen, Germany) is a swallowable, wireless, sensor capsule designed for in vivo detection of liquid blood or hematin. The capsule has integrated optical microsensor for blood detection, by transmitting red and violet light via LEDs. It allows the detection of blood by photometric measuring method, in small volumes or in unprepared digestive tract. The dimensions of the capsules are 7.0mm x 26.3mm. The maximal examination time is 9 hours. The HemoPill® receiver is a portable receiver for displaying and storing measured values from the HemoPill® acute capsule. It allows a real-time, wireless, telemetric data transmission. Once activated, the HemoPill® acute capsule can be swallowed by patients with real-time measurement of HemoPill® Indicator (HI). An HI value in the red range suggests a positive finding - liquid blood or hematin has been detected.
Related Therapeutic Areas
Sponsors
Leads: Chinese University of Hong Kong