MelenaHemopill-ProNCT06715293
A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB
A study testing Hemopill and OGD in people with Melena and Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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%). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melena, Gastrointestinal Bleeding, Hematemesis
- What is being tested?
- Hemopill and OGD
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Nov 2025to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
Prince of Wales Hospital
Shatin, Hong Kong Island
Felix Sia, 26370428, felixsia@cuhk.edu.hk
About this study
Official title: 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).
Read the 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.
- Conditions
- Melena, Gastrointestinal Bleeding, Hematemesis
- Being tested
- Hemopill, OGD
- Keywords
- GIB, gastrointestinal bleeding, melena, per rectal bleeding, coffee ground vomiting, hematemesis
- Medical subject headings
- Melena, Gastrointestinal Hemorrhage, Hematemesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HemopillDevice
Hemopill will be swallowed to detect the presence of active bleeding in the upper GI tract
OGDProcedure or surgery
OGD will be performed to compare the results of the hemopill
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Hemopill; Procedure: OGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of active bleeding
Presence of active bleeding, old blood or potential bleeding sources during OGD examination, which warrants endoscopic haemostatic treatment.
Measured: during OGD examination
Secondary outcomes (4)
Technical success rate
Technical success rate
Measured: during OGD examination
Adverse event rate
Adverse event rate
Measured: 30days post study procedure
Capsule retention rate
Capsule retention rate
Measured: 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
Measured: during OGD examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start5 Nov 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MelenaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- All patient will swallow Hemopill to observe the presence of active bleeding or potential bleeding source
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 193 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Ho Shing Lau, Chinese University of Hong Kong
- Investigators
- Louis HS Lau, FRCP, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715293
- Sponsor's protocol ID
- 2024.181
- Acronym
- Hemopill-Pro
- Status last verified
- Apr 2026
- First submitted
- 22 Nov 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study to Evaluate the Diagnostic Performance of a Wireless Optical Sensor Capsule in Detection of Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06715293
- Acronym / sponsor ID
- Hemopill-Pro / 2024.181
- Conditions
- Melena, Gastrointestinal Bleeding, Hematemesis
- Keywords
- GIB, gastrointestinal bleeding, melena, per rectal bleeding, coffee ground vomiting, hematemesis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 193 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 5 Nov 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- All patient will swallow Hemopill to observe the presence of active bleeding or potential bleeding source
| Arm | Type | Receives |
|---|---|---|
| Hemopill to detect the presence of active bleeding in the upper GI tract | Experimental | Device: Hemopill, Procedure: OGDHemopill to detect the presence of active bleeding in the upper GI tract |
| OGD to diagnose and treat active beleeding in the upper GI tract | Active comparator | Device: Hemopill, Procedure: OGDogd will be performed to compare the results with that of the hemopill |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemopillHemopill will be swallowed to detect the presence of active bleeding in the upper GI tract | Device | 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 |
| OGDOGD will be performed to compare the results of the hemopill | Procedure or surgery | 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 |
Primary outcome
Presence of active bleeding
Time frame: during OGD examination
Presence of active bleeding, old blood or potential bleeding sources during OGD examination, which warrants endoscopic haemostatic treatment.
4 secondary outcomes
Technical success rate
Time frame: during OGD examination
Adverse event rate
Time frame: 30days post study procedure
Capsule retention rate
Time frame: 30days post study procedure
Time from Hemopill acute capsule ingestion to a positive HI signal
Time frame: during OGD examination
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louis HS Lau, FRCP principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hemopill and OGD in people with Melena and Gastrointestinal Bleeding, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Louis HS Lau, FRCP (26370428, louishslau@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of active bleeding (time frame: during OGD examination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.