Trial Outcomes & Findings for Presence or Absence of Blood in the GI Lumen (NCT NCT05415124)

Results Overview

HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

15 participants

Primary outcome timeframe

1 hour after endoscopy procedure

Results posted on

2025-11-17

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	HemoPill Group n=15 Participants 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.
Age, Continuous	51 years STANDARD_DEVIATION 22.087 • n=15 Participants
Sex: Female, Male Female	10 Participants n=15 Participants
Sex: Female, Male Male	5 Participants n=15 Participants
Region of Enrollment United States	15 participants n=15 Participants

PRIMARY outcome

Timeframe: 1 hour after endoscopy procedure

HemoPill acute measurement positive; Endoscopy measurement positive. HemoPill acute measurement indicates presence of blood; Endoscopy identifies fresh blood or hematin in the GI lumen

Outcome measures

Outcome measures
Measure	HemoPill Group n=13 Participants 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.
Number of Participants With True Positive Results	3 Participants

PRIMARY outcome

Timeframe: 1 hour after endoscopy procedure

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.

Outcome measures

Outcome measures
Measure	HemoPill Group n=13 Participants 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.
Number of Participants With False Positive Results	3 Participants

PRIMARY outcome

Timeframe: 1 hour after endoscopy procedure

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.

Outcome measures

Outcome measures
Measure	HemoPill Group n=13 Participants 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.
Count of Participants With True Negative Results	5 Participants

PRIMARY outcome

Timeframe: 1 hour after endoscopy procedure

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.

Outcome measures

Outcome measures
Measure	HemoPill Group n=13 Participants 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.
Count of Participants With False Negative Results	2 Participants

Adverse Events

HemoPill Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Melissa Debordeaux, MD

NYU Langone Health

Phone: (212) 263-7300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place