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Presence or Absence of Blood in the GI Lumen

Primary Purpose

Upper GI Bleeding

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
HemoPill
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Upper GI Bleeding

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NYU Langone HealthRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HemoPIll group

Arm Description

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

Outcomes

Primary Outcome Measures

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
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 8, 2022
Last Updated
February 3, 2023
Sponsor
NYU Langone Health
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1. Study Identification

Unique Protocol Identification Number
NCT05415124
Brief Title
Presence or Absence of Blood in the GI Lumen
Official Title
Presence or Absence of Blood in the GI Lumen - Correlating a HemoPill Acute Measurement With a Subsequent Endoscopic Finding
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 17, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper GI Bleeding

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HemoPIll group
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
HemoPill
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of True positive results
Description
HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen
Time Frame
1 hour after endoscopy procedure
Title
Number of False positive results
Description
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.
Time Frame
1 hour after endoscopy procedure
Title
Number of True negative results
Description
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.
Time Frame
1 hour after endoscopy procedure
Title
Number of False negative results
Description
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.
Time Frame
1 hour after endoscopy procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sofia Yuen
Phone
646-501-7931
Email
sofia.yuen@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Melissa Latorre, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sofia Yuen
Phone
646-501-7931
Email
sofia.yuen@nyulangone.org
First Name & Middle Initial & Last Name & Degree
Melissa Latorre, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing 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.
IPD Sharing 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.

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Presence or Absence of Blood in the GI Lumen

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