Using a capsule to detect upper gastrointestinal bleeding
Usage of Novel Blood Sensing Capsule in Emergency Department to Triage Patients With Suspected Upper Gastrointestinal Bleeding
NA · Tan Tock Seng Hospital · NCT06500468
This study is testing a new capsule that can quickly check for bleeding in the stomach to help emergency doctors decide if patients can go home or need more treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 21 Years to 99 Years |
| Sex | All |
| Sponsor | Tan Tock Seng Hospital (other) |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06500468 on ClinicalTrials.gov |
What this trial studies
This study evaluates the efficacy and safety of the PillSense System, a novel blood-sensing capsule designed to help emergency doctors assess active upper gastrointestinal bleeding in patients. The PillSense Capsule is ingested by the patient and works in conjunction with an external monitor to provide real-time data on bleeding within 10 minutes. If no blood is detected, patients may be discharged safely, reducing their wait time in the emergency department. Conversely, if blood is detected, patients will be admitted for further evaluation and treatment. This approach aims to streamline patient management and improve overall hospital resource utilization.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 and older presenting with symptoms of acute overt upper gastrointestinal bleeding, such as coffee ground vomiting or melena.
Not a fit: Patients experiencing hemodynamic shock or those requiring urgent endoscopy or surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this system could significantly enhance the speed and accuracy of diagnosing upper gastrointestinal bleeding, leading to better patient outcomes.
How similar studies have performed: While the use of capsule endoscopy is established, this specific application of the PillSense System for rapid bleeding detection is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
Where this trial is running
Singapore
- Tan Tock Seng Hospital — Singapore, Singapore (RECRUITING)
Study contacts
- Principal investigator: Dr Ng Wee Khoon — Tan Tock Seng Hospital
- Study coordinator: Dr Ng Wee Khoon
- Email: wee_khoon_ng@ttsh.com.sg
- Phone: +65 8938 1462
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bleeding Ugi, capsule endoscopy, upper gastrointestinal bleeding, melena, coffee ground vomitting, emergency department, triage