Prince of Wales Hospital
Hong Kong
NCT Number: NCT06409182
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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Interventional
Not applicable
Hong Kong
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Subjects are eligible if:
Exclusion criteria
Subjects will be excluded from the study if they have any of the followings:
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.
Time frame: 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.
Time frame: duration of study, 2 hours
Sensitivity of Hemopill
Time frame: duration of study, 2 hours
Specificity of Hemopill
Time frame: duration of study, 2 hours
Positive predictive value of Hemopill
Time frame: duration of study, 2 hours
Negative predicitive value of Hemopill
Time frame: duration of study, 2 hours
Technical success rate of Hemopill
Time frame: duration of study, 2 hours
Adverse event rate of Hemopill
Time frame: duration of study, 2 hours
Time to a positive HI signal of Hemopill
Time frame: duration of study, 2 hours
Time to OGD from Hemopill capsule examination
Chinese University of Hong Kong
Other
A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of Upper Gastrointestinal Bleeding
Acronym: HemoPill
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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