UGI Bleed
Conditions
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).
Interventions
DEVICEHemopill
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Patient will swallow wireless sensor capsule to determine if there's
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | duration of study, 2 hours | Sensitivity of Hemopill |
| Specificity | duration of study, 2 hours | Specificity of Hemopill |
| Positive predictive value | duration of study, 2 hours | Positive predictive value of Hemopill |
| Negative predictive value | duration of study, 2 hours | Negative predicitive value of Hemopill |
| Technical success rate | duration of study, 2 hours | Technical success rate of Hemopill |
| Adverse event rate | duration of study, 2 hours | Adverse event rate of Hemopill |
| Time to a positive HI signal | duration of study, 2 hours | Time to a positive HI signal of Hemopill |
| Time to OGD from Hemopill capsule examination | duration of study, 2 hours | Time to OGD from Hemopill capsule examination |
Countries
Hong Kong
Outcome results
None listed