NCT06500468 PillSense for Suspected Upper Gastrointestinal Bleeding
| NCT ID | NCT06500468 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tan Tock Seng Hospital |
| Condition | Bleeding Ugi |
| Study Type | INTERVENTIONAL |
| Enrollment | 84 participants |
| Start Date | 2024-07-18 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 84 participants in total. It began in 2024-07-18 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility 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
Contact & Investigator
Dr Ng Wee Khoon
PRINCIPAL INVESTIGATOR
Tan Tock Seng Hospital
Frequently Asked Questions
Who can join the NCT06500468 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 99 Years, studying Bleeding Ugi. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06500468 currently recruiting?
Yes, NCT06500468 is actively recruiting participants. Contact the research team at wee_khoon_ng@ttsh.com.sg for enrollment information.
Where is the NCT06500468 trial being conducted?
This trial is being conducted at Singapore, Singapore.
Who is sponsoring the NCT06500468 clinical trial?
NCT06500468 is sponsored by Tan Tock Seng Hospital. The principal investigator is Dr Ng Wee Khoon at Tan Tock Seng Hospital. The trial plans to enroll 84 participants.