Bleeding UgiBLEEDNCT06500468
PillSense for Suspected Upper Gastrointestinal Bleeding
A study testing PillSense System in people with Bleeding Ugi, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Bleeding Ugi
- What is being tested?
- PillSense System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSingapore
- Study dates
- 18 Jul 2024to Jan 2026
- 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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 21 years and above and are able to give consent.
- Patients who are willing and able to comply with the study protocol (including undergoing endoscopy)
- Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting and melena (but without melaena on physical examination)
Who cannot join
- Patients who had hemodynamic shock (systolic blood pressure below 90 mm Hg and pulse rate over 120/min)
- Patients who presented with fresh hematemesis, hematochezia and/or melaena
- Patients requiring urgent endoscopy / surgery at time of review or already planned for admission by ED physician for non UGIB related indications
- Patients who had conditions that might contraindicate the use of an ingestible capsule, such as capsule endoscopy (eg. Dysphagia, odynophagia, swallowing disorder, and/or Zenker's diverticulum, issues with the motility of the gastrointestinal tract, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction and/or perforation)
- Patients with a known history of oesophageal or gastric varices
- Patients with known UGI pathology (such as oesophageal/gastric cancer), or recent (within 3 months) upper GI ulcer bleeding, upper GI surgeries or procedures
Show all 11Show fewer
- Patients who are on anticoagulation
- Patients with cardiac implantable electrical device (CIED)
- Patients who had altered mental status
- Pregnant and/or lactating women (Female patients below age 60, without history of hysterectomy or are not documented to be post-menopausal, will be given a urine pregnancy test to confirm they are not pregnant)
- Patients who have an MRI investigation planned within 2 weeks
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding
This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.
Read the detailed description
The use of the PillSense System enables the clinician to make a more informed choice on the treatment plan for the patient. If the system revealed "No Blood Detected", this is suggestive there is absence of blood in the stomach. Together with the presenting symptoms, physical examination and laboratory tests, it gives the emergency physician a more accurate method to detect if patient is actively bleeding. If patient remained stable during the monitoring, the patient can be discharged home for early outpatient review, instead of waiting in Emergency Department (ED) for prolonged duration to be admitted and wait in the ward for investigations like gastroscopy to be performed. This reduces unnecessary strain on the hospital's limited resources and may improve overall patient's experience. Patients with 'Blood Detected' result will be admitted with early gastroscopy planned within 72 hours. Patients with 'No Blood Detected' result, will be monitored closely in ED and, if deemed to be stable, to be discharged with an outpatient gastroscopy within 96 hours. A product such as the PillSense System which employs a minimally invasive method to help clinicians detect whether or not a patient has blood in upper gastrointestinal tract within 10 minutes. This will be a quick and objective tool to determine if the patient is having active upper gastrointestinal bleeding (UGIB), to assist in triaging patients for more emergent definitive care. This system can also be easily administered by non-clinician and do not require special training to read the results, minimising the need for highly specialised staff to provide this service. The information provided by the PillSense System which taken together with other clinical parameters may lead to more efficient, safer and higher quality patient care.
- Conditions
- Bleeding Ugi
- Being tested
- PillSense System
- Keywords
- capsule endoscopy, upper gastrointestinal bleeding, melena, coffee ground vomitting, emergency department, triage
- Medical subject headings
- Gastrointestinal Hemorrhage, Melena, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillSense SystemDevice
The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display. The PillSense Capsule is a minimally invasive, single use medical device designed to detect the presence of bleeding in the upper digestive tract, to aid with patient care. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule within 10 minutes. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No blood detected".
| Study group | Role | What they receive |
|---|---|---|
| PillSense group | Experimental | Participants in the PillSense arm will swallow one PillSense capsule. Participants who have blood detected will be admitted with a scheduled oesophagogastroduodenoscopy within 72 hours. Participants with no blood detected will be discharged with medications and a scheduled OGD within 96 hours. Receives: Device: PillSense System |
| Standard group | No intervention | Participants randomized to the standard arm will follow standard of care and will either be admitted or discharged with medications and to undergo an oesophagogastroduodenoscopy (OGD) within 72 hours if admitted or 96 hours if discharged. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit
To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment.
Measured: 1.5 years
Secondary outcomes (5)
Risk of clinical rebleeding after a negative PillSense reading
To measure the number of patients who have clinical re-bleeding in both arms.
Measured: 1.5 years
Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS).
To compare what is the percentage of patients who can be discharged safely using PillSense vs Glasgow Blatchford Score alone. The Glasgow Blatchford Score (GBS) is a risk assessment tool to help triage patients presenting with upper gastrointestinal bleeding, if they can be discharged safely from emergency department for outpatient care. The score may range from 0 to 23 and higher scores are associated with higher risks of complications related to gastrointestinal bleeding. Conventional studies recommend that such patients can be safely discharged if the score is 0.
Measured: 1.5 years
Number of inpatient beds saved from this arrangement
To review the beds and potential cost savings from the hospital from the reduction of admissions
Measured: 1.5 years
Risk of patient morbidity after a negative PillSense reading
To quantify and specify any patient morbidity after a negative PillSense reading.
Measured: 1.5 years
Risk of patient mortality after a negative PillSense reading
To quantify and specify any mortality after a negative PillSense reading.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start18 Jul 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Bleeding UgiStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Partipants will be randomised into either of the 2 arms: PillSense Group (Treatment arm) or Standard group (where they will receive standard of care) for the duration of the study.
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- EnteraSense Limited
- Responsible party
- Principal investigator, Wee Khoon Ng, Tan Tock Seng Hospital
- Investigators
- Dr Ng Wee Khoon, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06500468
- Sponsor's protocol ID
- 2024/00060
- Acronym
- BLEED
- Status last verified
- Dec 2024
- First submitted
- 6 Jul 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Gleeson F, Clarke E, Lennon J, MacMathuna R, Crowe J. Outcome of accident and emergency room triaged patients with low risk non-variceal upper gastrointestinal haemorrhage. Ir Med J. 2006 Apr;99(4):114-7.
PubMed 16972584Owensby S, Taylor K, Wilkins T. Diagnosis and management of upper gastrointestinal bleeding in children. J Am Board Fam Med. 2015 Jan-Feb;28(1):134-45. doi: 10.3122/jabfm.2015.01.140153.
PubMed 25567834Biecker E, Heller J, Schmitz V, Lammert F, Sauerbruch T. Diagnosis and management of upper gastrointestinal bleeding. Dtsch Arztebl Int. 2008 Feb;105(5):85-94. doi: 10.3238/arztebl.2008.0085. Epub 2008 Feb 1.
PubMed 19633792Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.
PubMed 16457402Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
PubMed 7627034Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316.
PubMed 8675081Zimmerman J, Meroz Y, Arnon R, Tsvang E, Siguencia J. Predictors of mortality in hospitalized patients with secondary upper gastrointestinal haemorrhage. J Intern Med. 1995 Mar;237(3):331-7. doi: 10.1111/j.1365-2796.1995.tb01183.x.
PubMed 7891055Schembre DB, Ely RE, Connolly JM, Padhya KT, Sharda R, Brandabur JJ. Semiautomated Glasgow-Blatchford Bleeding Score helps direct bed placement for patients with upper gastrointestinal bleeding. BMJ Open Gastroenterol. 2020 Nov;7(1):e000479. doi: 10.1136/bmjgast-2020-000479.
PubMed 33214231Fisher L, Fisher A, Pavli P, Davis M. Perioperative acute upper gastrointestinal haemorrhage in older patients with hip fracture: incidence, risk factors and prevention. Aliment Pharmacol Ther. 2007 Feb 1;25(3):297-308. doi: 10.1111/j.1365-2036.2006.03187.x. Epub 2007 Jan 8.
PubMed 17217452Sengupta N. Integrating Gastrointestinal Bleeding Risk Scores into Clinical Practice. Am J Gastroenterol. 2019 Nov;114(11):1699-1703. doi: 10.14309/ajg.0000000000000417. No abstract available.
PubMed 31592783Sachdev MS, Leighton JA, Fleischer DE, Heigh RI, Hara AK, Post JA, Erickson PJ, Sharma VK. A prospective study of the utility of abdominal radiographs after capsule endoscopy for the diagnosis of capsule retention. Gastrointest Endosc. 2007 Nov;66(5):894-900. doi: 10.1016/j.gie.2007.06.066.
PubMed 17963875Rezapour M, Amadi C, Gerson LB. Retention associated with video capsule endoscopy: systematic review and meta-analysis. Gastrointest Endosc. 2017 Jun;85(6):1157-1168.e2. doi: 10.1016/j.gie.2016.12.024. Epub 2017 Jan 6.
PubMed 28069475Fernandez-Urien I, Carretero C, Gonzalez B, Pons V, Caunedo A, Valle J, Redondo-Cerezo E, Lopez-Higueras A, Valdes M, Menchen P, Fernandez P, Munoz-Navas M, Jimenez J, Herrerias JM. Incidence, clinical outcomes, and therapeutic approaches of capsule endoscopy-related adverse events in a large study population. Rev Esp Enferm Dig. 2015 Dec;107(12):745-52. doi: 10.17235/reed.2015.3820/2015.
PubMed 26671587Liao Z, Gao R, Xu C, Li ZS. Indications and detection, completion, and retention rates of small-bowel capsule endoscopy: a systematic review. Gastrointest Endosc. 2010 Feb;71(2):280-6. doi: 10.1016/j.gie.2009.09.031.
PubMed 20152309Lim YJ, Lee OY, Jeen YT, Lim CY, Cheung DY, Cheon JH, Ye BD, Song HJ, Kim JS, Do JH, Lee KJ, Shim KN, Chang DK, Park CH, Jang BI, Moon JS, Chun HJ, Choi MG, Kim JO; Korean Gut Image Study Group. Indications for Detection, Completion, and Retention Rates of Small Bowel Capsule Endoscopy Based on the 10-Year Data from the Korean Capsule Endoscopy Registry. Clin Endosc. 2015 Sep;48(5):399-404. doi: 10.5946/ce.2015.48.5.399. Epub 2015 Sep 30.
PubMed 26473123
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06500468
- Acronym / sponsor ID
- BLEED / 2024/00060
- Conditions
- Bleeding Ugi
- Keywords
- capsule endoscopy, upper gastrointestinal bleeding, melena, coffee ground vomitting, emergency department, triage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- EnteraSense Limited
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 15 Jul 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.
This study aims to evaluate the efficacy and safety of a novel blood sensing capsule (PillSense), to help emergency doctors better evaluate if patients have active upper digestive tract bleeding, to determine if they can be discharged safely. The PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display to detect the presence of bleeding in the upper digestive tract within 10 minutes.
Detailed description
The use of the PillSense System enables the clinician to make a more informed choice on the treatment plan for the patient. If the system revealed "No Blood Detected", this is suggestive there is absence of blood in the stomach. Together with the presenting symptoms, physical examination and laboratory tests, it gives the emergency physician a more accurate method to detect if patient is actively bleeding. If patient remained stable during the monitoring, the patient can be discharged home for early outpatient review, instead of waiting in Emergency Department (ED) for prolonged duration to be admitted and wait in the ward for investigations like gastroscopy to be performed. This reduces unnecessary strain on the hospital's limited resources and may improve overall patient's experience. Patients with 'Blood Detected' result will be admitted with early gastroscopy planned within 72 hours. Patients with 'No Blood Detected' result, will be monitored closely in ED and, if deemed to be stable, to be discharged with an outpatient gastroscopy within 96 hours. A product such as the PillSense System which employs a minimally invasive method to help clinicians detect whether or not a patient has blood in upper gastrointestinal tract within 10 minutes. This will be a quick and objective tool to determine if the patient is having active upper gastrointestinal bleeding (UGIB), to assist in triaging patients for more emergent definitive care. This system can also be easily administered by non-clinician and do not require special training to read the results, minimising the need for highly specialised staff to provide this service. The information provided by the PillSense System which taken together with other clinical parameters may lead to more efficient, safer and higher quality patient care.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Partipants will be randomised into either of the 2 arms: PillSense Group (Treatment arm) or Standard group (where they will receive standard of care) for the duration of the study.
| Arm | Type | Receives |
|---|---|---|
| PillSense group | Experimental | Device: PillSense SystemParticipants in the PillSense arm will swallow one PillSense capsule. Participants who have blood detected will be admitted with a scheduled oesophagogastroduodenoscopy within 72 hours. Participants with no blood detected will be discharged with medications and a scheduled OGD within 96 hours. |
| Standard group | No intervention | –Participants randomized to the standard arm will follow standard of care and will either be admitted or discharged with medications and to undergo an oesophagogastroduodenoscopy (OGD) within 72 hours if admitted or 96 hours if discharged. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females aged 21 years and above and are able to give consent.
- Patients who are willing and able to comply with the study protocol (including undergoing endoscopy)
- Presented to Emergency Department with symptoms of acute overt upper gastrointestinal bleeding such as coffee ground vomiting and melena (but without melaena on physical examination)
Key exclusion criteria (11 listed)
- Patients who had hemodynamic shock (systolic blood pressure below 90 mm Hg and pulse rate over 120/min)
- Patients who presented with fresh hematemesis, hematochezia and/or melaena
- Patients requiring urgent endoscopy / surgery at time of review or already planned for admission by ED physician for non UGIB related indications
- Patients who had conditions that might contraindicate the use of an ingestible capsule, such as capsule endoscopy (eg. Dysphagia, odynophagia, swallowing disorder, and/or Zenker's diverticulum, issues with the motility of the gastrointestinal tract, Crohn's disease, previous GI surgery, suspected ileus, bowel obstruction and/or perforation)
- Patients with a known history of oesophageal or gastric varices
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 |
|---|---|---|
| PillSense SystemThe PillSense System consists of the PillSense Capsule, a small single use capsule that is safe for human consumption and PillSense Receiver, an external real-time monitor for data display. The PillSense Capsule is a minimally invasive, single use medical device designed to detect the presence of bleeding in the upper digestive tract, to aid with patient care. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule within 10 minutes. The PillSense Receiver interprets the data and displays a result message "Blood detected" or "No blood detected". | Device | PillSense group |
Primary outcome
Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit
Time frame: 1.5 years
To compare the percentage of patients who are safely discharged from ED visit with the usage of PillSense, compared to standard treatment.
5 secondary outcomes
Risk of clinical rebleeding after a negative PillSense reading
Time frame: 1.5 years
Discharge rate of patients who can be triaged home using PillSense , compared to conventional clinical scoring system like Glasgow Blatchford Score (GBS).
Time frame: 1.5 years
Number of inpatient beds saved from this arrangement
Time frame: 1.5 years
Risk of patient morbidity after a negative PillSense reading
Time frame: 1.5 years
Risk of patient mortality after a negative PillSense reading
Time frame: 1.5 years
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 10 Dec 2024.
- Background: PubMed 16972584Gleeson F, Clarke E, Lennon J, MacMathuna R, Crowe J. Outcome of accident and emergency room triaged patients with low risk non-variceal upper gastrointestinal haemorrhage. Ir Med J. 2006 Apr;99(4):114-7.
- Background: PubMed 25567834Owensby S, Taylor K, Wilkins T. Diagnosis and management of upper gastrointestinal bleeding in children. J Am Board Fam Med. 2015 Jan-Feb;28(1):134-45. doi: 10.3122/jabfm.2015.01.140153.
- Background: PubMed 19633792Biecker E, Heller J, Schmitz V, Lammert F, Sauerbruch T. Diagnosis and management of upper gastrointestinal bleeding. Dtsch Arztebl Int. 2008 Feb;105(5):85-94. doi: 10.3238/arztebl.2008.0085. Epub 2008 Feb 1.
- Background: PubMed 16457402Ferguson CB, Mitchell RM. Non-variceal upper gastrointestinal bleeding. Ulster Med J. 2006 Jan;75(1):32-9. No abstract available.
- Background: PubMed 7627034Rockall TA, Logan RF, Devlin HB, Northfield TC. Incidence of and mortality from acute upper gastrointestinal haemorrhage in the United Kingdom. Steering Committee and members of the National Audit of Acute Upper Gastrointestinal Haemorrhage. BMJ. 1995 Jul 22;311(6999):222-6. doi: 10.1136/bmj.311.6999.222.
- Background: PubMed 8675081Rockall TA, Logan RF, Devlin HB, Northfield TC. Risk assessment after acute upper gastrointestinal haemorrhage. Gut. 1996 Mar;38(3):316-21. doi: 10.1136/gut.38.3.316.
- Background: PubMed 7891055Zimmerman J, Meroz Y, Arnon R, Tsvang E, Siguencia J. Predictors of mortality in hospitalized patients with secondary upper gastrointestinal haemorrhage. J Intern Med. 1995 Mar;237(3):331-7. doi: 10.1111/j.1365-2796.1995.tb01183.x.
- Background: PubMed 33214231Schembre DB, Ely RE, Connolly JM, Padhya KT, Sharda R, Brandabur JJ. Semiautomated Glasgow-Blatchford Bleeding Score helps direct bed placement for patients with upper gastrointestinal bleeding. BMJ Open Gastroenterol. 2020 Nov;7(1):e000479. doi: 10.1136/bmjgast-2020-000479.
- Background: PubMed 17217452Fisher L, Fisher A, Pavli P, Davis M. Perioperative acute upper gastrointestinal haemorrhage in older patients with hip fracture: incidence, risk factors and prevention. Aliment Pharmacol Ther. 2007 Feb 1;25(3):297-308. doi: 10.1111/j.1365-2036.2006.03187.x. Epub 2007 Jan 8.
- Background: PubMed 31592783Sengupta N. Integrating Gastrointestinal Bleeding Risk Scores into Clinical Practice. Am J Gastroenterol. 2019 Nov;114(11):1699-1703. doi: 10.14309/ajg.0000000000000417. No abstract available.
- Background: PubMed 17963875Sachdev MS, Leighton JA, Fleischer DE, Heigh RI, Hara AK, Post JA, Erickson PJ, Sharma VK. A prospective study of the utility of abdominal radiographs after capsule endoscopy for the diagnosis of capsule retention. Gastrointest Endosc. 2007 Nov;66(5):894-900. doi: 10.1016/j.gie.2007.06.066.
- Background: PubMed 28069475Rezapour M, Amadi C, Gerson LB. Retention associated with video capsule endoscopy: systematic review and meta-analysis. Gastrointest Endosc. 2017 Jun;85(6):1157-1168.e2. doi: 10.1016/j.gie.2016.12.024. Epub 2017 Jan 6.
- 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.
Dr Ng Wee Khoon principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillSense System in people with Bleeding Ugi, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 11 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 10 Dec 2024. 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 Singapore. 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 Dr Ng Wee Khoon (+65 8938 1462, wee_khoon_ng@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Discharge rate of patients with stable UGIB who can be triaged home safely after ED visit (time frame: 1.5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06500468, which also lists 19 linked publications.
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 10 Dec 2024.