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A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB

NCT06715293 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 193

Last updated 2026-04-22

No results posted yet for this study

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).

Conditions

  • Melena
  • Gastrointestinal Bleeding
  • Hematemesis

Interventions

DEVICE

Hemopill

Hemopill will be swallowed to detect the presence of active bleeding in the upper GI tract

PROCEDURE

OGD

OGD will be performed to compare the results of the hemopill

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Louis HS Lau, FRCP · Chinese University of Hong Kong

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-05
Primary Completion
2027-10-31
Completion
2028-04-30

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715293 on ClinicalTrials.gov