Using a capsule to detect upper gastrointestinal bleeding

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.