A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB (Hemopill-Pro)

A Prospective Study to Evaluate the Diagnostic Performance of a Wireless Optical Sensor Capsule in Detection of Upper Gastrointestinal Bleeding

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).

Study Overview

• Status: Recruiting
• Conditions: Gastrointestinal Bleeding; Melena; Hematemesis
• Intervention / Treatment: Device: Hemopill; Procedure: OGD

Detailed Description

From December 2023 to February 2024, the investigator conducted a pilot study and screened 51 adult subjects with symptoms and signs of suspected UGIB in Prince of Wales Hospital. Among them, the investigator recruited 20 eligible subjects to receive HemoPill® examination before oesophago-gastro-duodenoscopy (OGD). The overall sensitivity was 80% with a negative predictive value of 87.5%. The area-under-receiver-operating-characteristic curve was 0.633.

The pilot data demonstrated a huge potential for this novel, non-invasive, easy-to-use device as UGIB screening in the real-world. A large-scale, prospective validation study will be conducted to evaluate the diagnostic performance of the new generation HemoPill® acute capsule in UGIB.

• Study Type: Interventional
• Enrollment (Estimated): 193
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Louis HS Lau, FRCP; Phone Number: 26370428; Email: louishslau@cuhk.edu.hk
• Study Contact Backup: Name: Felix Sia, MSc; Phone Number: 852-2637-0428; Email: felixsia@cuhk.edu.hk

Study Locations

• Hong Kong
  • Hong Kong Island
    • Shatin, Hong Kong Island, Hong Kong
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Felix Sia; Phone Number: 26370428; Email: felixsia@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hemopill to detect the presence of active bleeding in the upper GI tract	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
Active Comparator: OGD to diagnose and treat active beleeding in the upper GI tract; ogd will be performed to compare the results with that of the hemopill	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of active bleeding	Presence of active bleeding, old blood or potential bleeding sources during OGD examination, which warrants endoscopic haemostatic treatment.	during OGD examination

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success rate	Technical success rate	during OGD examination
Adverse event rate	Adverse event rate	30days post study procedure
Capsule retention rate	Capsule retention rate	30days post study procedure
Time from Hemopill acute capsule ingestion to a positive HI signal	Time from Hemopill acute capsule ingestion to a positive HI signal	during OGD examination

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Louis HS Lau, FRCP, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: November 22, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 20, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: melena; hematemesis; gastrointestinal bleeding; GIB; per rectal bleeding; coffee ground vomiting
• Additional Relevant MeSH Terms: Pathologic Processes; Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Hemorrhage; Vomiting; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastrointestinal Hemorrhage; Melena; Hematemesis
• Other Study ID Numbers: 2024.181

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We are currently deciding

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No