Presence or Absence of Blood in the GI Lumen

Upper GI Bleeding Clinical Trial

Official title:

Presence or Absence of Blood in the GI Lumen - Correlating a HemoPill Acute Measurement With a Subsequent Endoscopic Finding

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05415124
• Other study ID #: 22-00387
• Status: Recruiting
• Phase: N/A
• Start date: June 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Sofia Yuen
• Phone: 646-501-7931
• Email: sofia.yuen[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Upper GI Bleeding

Intervention

Device:
• HemoPill
The HemeoPill acute capsule is a small, single use, swallowable capsule with optical sensor. Blood detection by direct measurement of blood in the sensor gap, even in an unprepared digestive tract. Wireless transmission of measured values to the HemoPill Receiver. The maximum measuring time is 9 hours. The length of the capsule is 26.3 mm and the diameter is 7.0 mm.

Locations

Country	Name	City	State
United States	NYU Langone Health	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of True positive results	HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen	1 hour after endoscopy procedure
Primary	Number of False positive results	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.	1 hour after endoscopy procedure
Primary	Number of True negative results	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.	1 hour after endoscopy procedure
Primary	Number of False negative results	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.	1 hour after endoscopy procedure