A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB

Launched by CHINESE UNIVERSITY OF HONG KONG · May 8, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called the HemoPill® capsule, which is a small, wireless sensor that can help detect upper gastrointestinal bleeding (UGIB). The goal is to see how well this capsule performs compared to a standard procedure called an oesophago-gastro-duodenoscopy (OGD), where a doctor looks inside the stomach and upper intestines. If you have symptoms like black stools, rectal bleeding, or vomiting that looks like coffee grounds, and you're scheduled to have an OGD within the next day, you might be eligible to participate in this study.

If you join the trial, you will take the HemoPill® capsule before your OGD, and doctors will compare the results from both tests. It's important to know that there are some reasons you might not be able to participate, such as if you have certain medical conditions, are pregnant, or have had specific surgeries. Overall, this study aims to find out if the HemoPill® capsule can be a helpful tool for diagnosing bleeding in the upper digestive tract, which could lead to better care for patients in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects are eligible if:
• • They have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, history of hematemesis);
• • They will undergo OGD within 24 hours;
• • Written consent obtained.
• Exclusion Criteria:
• Subjects will be excluded from the study if they have any of the followings:
• • Contraindications for OGD (e.g. respiratory failure, suspected perforation);
• • Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness);
• • Cardiac pacemaker or implanted electromedical devices;
• • History of gastrectomy or bowel resection;
• • Active ongoing fresh hematemesis;
• • Unstable hemodynamics despite adequate resuscitation;
• • Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above);
• • Pregnancy.