Clinical trial NCT05415124: 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
Overall status: COMPLETED
Phase: NA
Conditions: Upper GI Bleeding
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2022-06-10
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Number of True positive results
timeFrame: 1 hour after endoscopy procedure
measure: Number of False positive results
timeFrame: 1 hour after endoscopy procedure
measure: Number of True negative results
timeFrame: 1 hour after endoscopy procedure
measure: Number of False negative results
timeFrame: 1 hour after endoscopy procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Melissa Latorre, MD
role: PRINCIPAL_INVESTIGATOR
References: