Upper GI Bleeding
Conditions
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.
Interventions
DEVICEHemoPill
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.
PROCEDUREEndoscopy
Endoscopy is performed as scheduled.
Sponsors
NYU Langone Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With True Positive Results | 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 |
| Number of Participants With False Positive Results | 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. |
| Count of Participants With True Negative Results | 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. |
| Count of Participants With False Negative Results | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 15 |
| Total | 15 |
Baseline characteristics
| Characteristic | HemoPill Group | — |
|---|---|---|
| Age, Continuous | 51 years STANDARD_DEVIATION 22.087 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 15 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 15 |
| other Total, other adverse events | 0 / 15 |
| serious Total, serious adverse events | 0 / 15 |
Outcome results
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.
Time frame: 1 hour after endoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Group | Count of Participants With False Negative Results | 2 Participants |
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.
Time frame: 1 hour after endoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Group | Count of Participants With True Negative Results | 5 Participants |
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.
Time frame: 1 hour after endoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Group | Number of Participants With False Positive Results | 3 Participants |
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
Time frame: 1 hour after endoscopy procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HemoPill Group | Number of Participants With True Positive Results | 3 Participants |