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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).
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hemopill | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hemopill | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Area under the ROC curve | 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. | duration of study, 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity | Sensitivity of Hemopill | duration of study, 2 hours |
| Specificity | Specificity of Hemopill | duration of study, 2 hours |
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Inclusion Criteria:
Subjects are eligible if:
Exclusion Criteria:
Subjects will be excluded from the study if they have any of the followings:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Hong Kong |
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Patient will swallow wireless sensor capsule to determine if there's
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| Positive predictive value | Positive predictive value of Hemopill | duration of study, 2 hours |
| Negative predictive value | Negative predicitive value of Hemopill | duration of study, 2 hours |
| Technical success rate | Technical success rate of Hemopill | duration of study, 2 hours |
| Adverse event rate | Adverse event rate of Hemopill | duration of study, 2 hours |
| Time to a positive HI signal | Time to a positive HI signal of Hemopill | duration of study, 2 hours |
| Time to OGD from Hemopill capsule examination | Time to OGD from Hemopill capsule examination | duration of study, 2 hours |