A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in … (NCT06409182) | Clinical Trial Compass
CompletedNot Applicable
A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB
Hong Kong30 participantsStarted 2023-12-19
Plain-language 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).
Who can participate
SexALL
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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.