A Study to Evaluate the Performance of a Wireless Optical Sensor Capsule in Detection of UGIB

Launched by CHINESE UNIVERSITY OF HONG KONG · Dec 3, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the HemoPill®, a wireless capsule designed to help detect bleeding in the upper part of the gastrointestinal tract (UGIB), which can be a serious medical issue. The goal is to see how well this capsule can identify patients who may need urgent medical treatment. Current methods for assessing bleeding risk are not always accurate, so researchers hope that the HemoPill® can provide better information for doctors to decide on the best care for their patients.

To be eligible for this trial, participants need to have symptoms suggesting UGIB, such as black or bloody stools or vomiting blood, and they must be scheduled for a procedure called an OGD (which is a way for doctors to look inside the stomach) within 24 hours. Participants will swallow the HemoPill® capsule, which is generally well-tolerated, and they will be monitored for results. This trial is important because it may lead to more effective ways to manage UGIB, potentially reducing unnecessary procedures for patients who are not actively bleeding.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participants have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, prior hematemesis);
• • 2. Participants will undergo urgent or elective OGD within 24 hours from recruitment;
• • 3. Written consent obtained.
• Exclusion Criteria:
• • 1. Contraindications for OGD (e.g. respiratory failure, suspected perforation);
• • 2. Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness);
• • 3. Cardiac pacemaker or implanted electromedical devices;
• • 4. History of gastrectomy or bowel resection;
• • 5. Ongoing fresh hematemesis requiring emergent endoscopy;
• • 6. Unstable hemodynamics despite adequate resuscitation requiring emergent endoscopy (i.e. systolic blood pressure \<100mmHg or pulse rate \>100 per minute);
• • 7. Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
• • 8. Pregnancy.