NCT06715293 A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB
| NCT ID | NCT06715293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Melena |
| Study Type | INTERVENTIONAL |
| Enrollment | 193 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2027-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 193 participants in total. It began in 2025-11-05 with a primary completion date of 2027-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Upper gastrointestinal bleeding (UGIB) is a common and potentially lethal medical emergency, which requires hospitalization and healthcare resources. Despite the changing epidemiology and advancement of endoscopic therapy in the recent decade, the all-cause mortality of UGIB remains high (\>2%). An accurate risk stratification is necessary to triage patients into low- or high-risk groups, in order to inform clinicians for the necessity and timing of urgent endoscopy. However, existing pre-endoscopy risk scores, such as the Glasgow-Blatchford score (GBS), Rockall score and AIMS65 score, are suboptimal in predicting relevant clinical outcomes. An alternative strategy for risk stratification is urgently warranted in patients with UGIB to guide the next step of management. In a pre-clinical study, the sensitivity and specificity of HemoPill® prototype were 95% and 87.5% respectively, when the sensors were positioned close to the bleeding point. Furthermore, several human clinical studies have proven the feasibility and accuracy of HemoPill® in healthy volunteers and patients with suspected UGIB. Capsule ingestion was well tolerated with no device-related adverse event or capsule retention. All patients with negative HI were found to have no active endoscopic bleeding (true negative, 100%, 17/17). In patients with bleeding \>20ml, true positive HI signals were detected (100%, 2/2) In a retrospective multi-center study, 61 patients with suspected UGIB were recruited to use HemoPill®. Among the capsule-positive cases, subsequent endoscopy confirmed active bleeding in 57% (20/35) of them. None of the capsule-negative patients rebled (0%, 0/25), which prevented unnecessary emergent endoscopy in 72% of them (18/25).
Eligibility Criteria
Inclusion Criteria: 1. Participants have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, prior hematemesis); 2. Participants will undergo urgent or elective OGD within 24 hours from recruitment; 3. Written consent obtained. Exclusion Criteria: 1. Contraindications for OGD (e.g. respiratory failure, suspected perforation); 2. Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness); 3. Cardiac pacemaker or implanted electromedical devices; 4. History of gastrectomy or bowel resection; 5. Ongoing fresh hematemesis requiring emergent endoscopy; 6. Unstable hemodynamics despite adequate resuscitation requiring emergent endoscopy (i.e. systolic blood pressure \<100mmHg or pulse rate \>100 per minute); 7. Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above); 8. Pregnancy.
Contact & Investigator
Louis HS Lau, FRCP
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT06715293 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Melena. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06715293 currently recruiting?
Yes, NCT06715293 is actively recruiting participants. Contact the research team at louishslau@cuhk.edu.hk for enrollment information.
Where is the NCT06715293 trial being conducted?
This trial is being conducted at Shatin, Hong Kong.
Who is sponsoring the NCT06715293 clinical trial?
NCT06715293 is sponsored by Chinese University of Hong Kong. The principal investigator is Louis HS Lau, FRCP at Chinese University of Hong Kong. The trial plans to enroll 193 participants.