A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB
- Conditions
- UGI Bleed
- Interventions
- Device: Hemopill
- Registration Number
- NCT06409182
- Lead Sponsor
- Chinese University of Hong Kong
- Brief 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).
- Detailed Description
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).
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 30
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.
Subjects will be excluded from the study if they have any of the followings:
- Contraindications for OGD (e.g. respiratory failure, suspected perforation);
- Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness);
- Cardiac pacemaker or implanted electromedical devices;
- History of gastrectomy or bowel resection;
- Active ongoing fresh hematemesis;
- Unstable hemodynamics despite adequate resuscitation;
- Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
- Pregnancy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Hemopill 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.
- Primary Outcome Measures
Name Time Method Area under the ROC curve duration of study, 2 hours The primary endpoint is the area-under-the-ROC curve (AUC) for HemoPill® capsule, which is defined by the true positive and false positive rates of HI signals.
- Secondary Outcome Measures
Name Time Method Negative predictive value duration of study, 2 hours Negative predicitive value of Hemopill
Adverse event rate duration of study, 2 hours Adverse event rate of Hemopill
Positive predictive value duration of study, 2 hours Positive predictive value of Hemopill
Technical success rate duration of study, 2 hours Technical success rate of Hemopill
Time to a positive HI signal duration of study, 2 hours Time to a positive HI signal of Hemopill
Sensitivity duration of study, 2 hours Sensitivity of Hemopill
Specificity duration of study, 2 hours Specificity of Hemopill
Time to OGD from Hemopill capsule examination duration of study, 2 hours Time to OGD from Hemopill capsule examination
Trial Locations
- Locations (1)
Prince of Wales Hospital
🇭🇰Hong Kong, Hong Kong