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New treatment option for Bleeding Ugi
Official title PillSense for Suspected Upper Gastrointestinal Bleeding
ClinicalTrials.gov ID: NCT06500468
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 99
You may be able to join if
- 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...
You likely can't join if
- 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...
- 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...
See the full eligibility 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)
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Singapore, Singapore
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Singapore, Singapore. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.