Evaluating a wireless sensor capsule for detecting upper gastrointestinal bleeding
A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of Upper Gastrointestinal Bleeding
NA · Chinese University of Hong Kong · NCT06409182
This study is testing a new wireless capsule called HemoPill® to see if it can effectively detect upper gastrointestinal bleeding compared to the standard procedure.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Sex | All |
| Sponsor | Chinese University of Hong Kong (other) |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT06409182 on ClinicalTrials.gov |
What this trial studies
This is a single-center, prospective pilot study conducted at Prince of Wales Hospital to assess the diagnostic performance of the HemoPill® acute capsule in detecting upper gastrointestinal bleeding (UGIB). Participants will undergo both the HemoPill examination and traditional oesophago-gastro-duodenoscopy (OGD) within a 24-hour period. The study aims to compare the effectiveness of the wireless sensor capsule against the standard diagnostic method. Written consent will be obtained from all subjects prior to participation.
Who should consider this trial
Good fit: Ideal candidates are individuals showing symptoms of suspected UGIB who are scheduled for OGD within 24 hours.
Not a fit: Patients with contraindications for OGD or capsule endoscopy, or those with advanced comorbidities, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and more efficient method for diagnosing upper gastrointestinal bleeding.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, indicating this may be a novel evaluation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (RECRUITING)
Study contacts
- Study coordinator: Felix Sia
- Email: felixsia@cuhk.edu.hk
- Phone: 26370428
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: UGI Bleed