Presence or Absence of Blood in the GI Lumen

Not Applicable

Completed

• Conditions: Upper GI Bleeding

• Registration Number: NCT05415124
• Lead Sponsor: NYU Langone Health

Brief Summary

Bleedings in the upper digestive tract are common. Usually, laboratory and clinical parameters are considered to establish a suspicion for a bleeding in the digestive tract and to estimate urgency of the situation. If these parameters suggest the presence of a bleeding in the digestive tract, endoscopies are often performed to further investigate a patient's status. The above-mentioned laboratory and clinical parameters are sometimes not specific enough to reliably identify a bleeding in the upper digestive tract. The HemoPill acute is capsule device, that has a built in sensor that detects blood in the upper digestive tract. This information is valuable for the medical personnel and complements the information that is obtained from other laboratory or clinical tests

Detailed Description

The purpose of the study was to access safety and accuracy of Hemopill and its receiver. Patients scheduled for endoscopy on the basis of suspected UGIB are generally eligible for inclusion into the trial. After patient screening, information and obtaining informed consent, a patient is enrolled into the trial. Shortly before the scheduled endoscopy is performed, the patient ingests a HemoPill acute. Endoscopy is performed as scheduled. Blood within the GI lumen is identified if present and pictures are taken. Pathologies, if found, are treated as per clinical standard. The HemoPill acute measurement regarding presence or absence of blood in the GI lumen is compared to observations made during endoscopy.

Study Timeline

• Study First Submitted: 2022-06-08
• Study First Submitted QC: 2022-06-08
• Study First Posted: 2022-06-10
• Study Start: 2022-06-17
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-16
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patient is scheduled for endoscopy due to suspicion of UGIB based on clinical and / or laboratory findings
• Signed informed consent
• Age ≥ 18 years
• Willingness and ability to participate in the study procedure

Exclusion Criteria

• Contraindications to the use of the HemoPill acute, such as:
• Known gastrointestinal obstruction, stricture, fistula, or diverticula
• Dysphagia or other swallowing disorders
• Pregnancy
• Incapacity to provide informed consent
• In patients with cardiac pacemakers and other implanted medical devices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Number of False positive results	1 hour after endoscopy procedure	HemoPill acute measurement positive; Endoscopy measurement negative. HemoPill acute measurement indicates presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen.
Number of False negative results	1 hour after endoscopy procedure	HemoPill acute measurement negative; Endoscopy measurement positive. HemoPill acute measurement does not indicate presence of blood in the GI lumen; Endoscopy identifies fresh blood or hematin in the GI lumen in quantities \> 20 mL; minimum latency of 20 minutes achieved.
Number of True positive results	1 hour after endoscopy procedure	HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen
Number of True negative results	1 hour after endoscopy procedure	HemoPill acute measurement negative; Endoscopy measurement negative. HemoPill acute measurement does not indicate presence of blood; Endoscopy does not identify fresh blood or hematin in the GI lumen in quantities \> 20 mL; Minimum latency of 20 minutes achieved.

Trial Locations

Locations (1)

NYU Langone Health; 🇺🇸 New York, New York, United States