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

NCT06715293 | Recruiting DMC

• 1 other identifier: 2024.181
• Study Type: interventional
• Target: 193
• Locations: 1 country
• Sites: 1

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).

Conditions

Melena; Gastrointestinal Bleeding; Hematemesis

Keywords

GIB; gastrointestinal bleeding; melena; per rectal bleeding; coffee ground vomiting; hematemesis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Technical success rate

  during OGD examination

• Adverse event rate

  30days post study procedure

• Capsule retention rate

  30days post study procedure

• Time from Hemopill acute capsule ingestion to a positive HI signal

  during OGD examination

Study Arms (2)

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

EXPERIMENTAL

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

Device: Hemopill; Procedure: OGD

OGD to diagnose and treat active beleeding in the upper GI tract

ACTIVE COMPARATOR

ogd will be performed to compare the results with that of the hemopill

Device: Hemopill; Procedure: OGD

Interventions

Hemopill DEVICE

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

Hemopill to detect the presence of active bleeding in the upper GI tract; OGD to diagnose and treat active beleeding in the upper GI tract

OGD PROCEDURE

OGD will be performed to compare the results of the hemopill

Hemopill to detect the presence of active bleeding in the upper GI tract; OGD to diagnose and treat active beleeding in the upper GI tract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, prior hematemesis);
• Participants will undergo urgent or elective OGD within 24 hours from recruitment;
• Written consent obtained.

You may not qualify if:

• 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;
• Ongoing fresh hematemesis requiring emergent endoscopy;
• Unstable hemodynamics despite adequate resuscitation requiring emergent endoscopy (i.e. systolic blood pressure \<100mmHg or pulse rate \>100 per minute);
• Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
• Pregnancy.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong Island, Hong Kong

RECRUITING

MeSH Terms

Conditions

Melena; Gastrointestinal Hemorrhage; Hematemesis

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Louis HS Lau, FRCP

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Louis HS Lau, FRCP

CONTACT

26370428; louishslau@cuhk.edu.hk

Felix Sia, MSc

CONTACT

852-2637-0428; felixsia@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Endoscopists will be blinded from the Hemopill capsule examination results.
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: All patient will swallow Hemopill to observe the presence of active bleeding or potential bleeding source

Study Record Dates

• First Submitted: November 22, 2024
• First Posted: December 4, 2024
• Study Start: November 5, 2025
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): April 30, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)