Presence or Absence of Blood in the GI Lumen

NCT05415124 | Completed Results FDA Device

• 1 other identifier: 22-00387
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Upper GI Bleeding

Outcome Measures

Primary Outcomes (4)

• Number of Participants With 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

• Number of Participants With 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

• Count of Participants With 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

• Count of Participants With 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

Study Arms (1)

HemoPill group

EXPERIMENTAL

Participants who have scheduled endoscopies will be given the HemoPill acute capsule and the HemoPill Receiver will be activated (connected to the HemPill). Approximately 20 to 60 minutes after HemoPill acute capsule ingestion, the endoscopy will start. The attending physician will proceed with the endoscopic intervention in accordance with clinical practice and NYU protocols, which is a standard procedure. In the case bleeding pathologies are found, these will be endoscopically treated as per clinical standard.For later evaluation of the HemoPill acute measurement, a statistical correlation of the obtained data from the HemoPill Acute measurement with the endoscopic findings will be performed. The HemoPill acute capsule travels through and leaves the body naturally

Device: HemoPill; Procedure: Endoscopy

Interventions

HemoPill DEVICE

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.

HemoPill group

Endoscopy PROCEDURE

Endoscopy is performed as scheduled.

HemoPill group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Melissa Debordeaux, MD
• Organization: NYU Langone Health

Melissa.Debordeaux@nyulangone.org

(212) 263-7300

Study Officials

• Melissa Debordeaux, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2022
• First Posted: June 10, 2022
• Study Start: June 17, 2022
• Primary Completion: October 22, 2024
• Study Completion: October 22, 2024
• Last Updated: November 17, 2025
• Results First Posted: November 17, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Melissa.latorre@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)