NCT06715293: Hemopill-Pro

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

Not yet recruiting NA Last updated 5 December 2024

What this trial tests

NA trial testing Hemopill in Melena in 193 participants. Not yet recruiting.

Timeline

1 February 2025

Primary endpoint
31 January 2027

31 July 2027

Quick facts

Lead sponsor	Chinese University of Hong Kong
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	single
Primary purpose	diagnostic
Enrollment	193
Start date	1 February 2025
Primary completion	31 January 2027
Estimated completion	31 July 2027

Drugs / interventions tested

• Hemopill
• OGD

Conditions studied

• Melena — all drugs for Melena →
• Gastrointestinal Bleeding — all drugs for Gastrointestinal Bleeding →
• Hematemesis — all drugs for Hematemesis →

Sponsor

Chinese University of Hong Kong

Who can join

18 and older, any sex, with Melena or Gastrointestinal Bleeding. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

No peer-reviewed publications indexed yet for this trial.