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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Melissa Debordeaux, MD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
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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| ID | Title | Description |
|---|---|---|
| FG000 | HemoPill Group | 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 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. Endoscopy: Endoscopy is performed as scheduled. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HemoPill Group | 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 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. Endoscopy: Endoscopy is performed as scheduled. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Count of Participants | Participants | 1 hour after endoscopy procedure |
|
Endoscopy procedure (Day 1)
Adverse event information collected during endoscopy procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HemoPill Group | 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 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. Endoscopy: Endoscopy is performed as scheduled. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Melissa Debordeaux, MD | NYU Langone Health | (212) 263-7300 | Melissa.Debordeaux@nyulangone.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 10, 2023 | Oct 21, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006471 | Gastrointestinal Hemorrhage |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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|
| Endoscopy | Procedure | Endoscopy is performed as scheduled. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Primary | 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. | Posted | Count of Participants | Participants | 1 hour after endoscopy procedure |
|
|
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| Primary | 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. | Posted | Count of Participants | Participants | 1 hour after endoscopy procedure |
|
|
|
| Primary | 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. | Posted | Count of Participants | Participants | 1 hour after endoscopy procedure |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D013514 | Surgical Procedures, Operative |