PillSense System for Detecting UGI Bleed

Study Overview
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Brief Summary
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This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Detailed Description
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Patient eligibility as set out in the inclusion/exclusion criteria for the clinical investigation will be reviewed prior to study enrollment. Prior to administering the PillSense Capsule, the PillSense Receiver will be paired with the PillSense Capsule. The PillSense Receiver collects and displays real-time information gathered by the PillSense Capsule. The PillSense Receiver interprets the data and displays a result message Blood detected or No Blood detected. The overall investigation from the PillSense Capsule activation and ingestion until the result message is displayed takes less than 10 minutes. Esophagogastroduodenoscopy (EGD) should be completed immediately or up to 4 hours after PillSense Capsule administration in each patient that receives a Blood detected or No blood detected result to confirm the result achieved with the PillSense System. The endoscopy will be conducted according to the site's standard of care. Prior to discharge each patient will undergo an X-Ray examination to evaluate for PillSense Capsule presence. Following discharge, if there is no verifiable evidence that the PillSense Capsule passed through the gastrointestinal tract (GIT) (such as a photograph of stool with capsule in it or photograph of the capsule alone), the patient may undergo an X-Ray examination at Day 7 ± 5 days and, if necessary, at Day 14± 7 days to ascertain the passage status of the PillSense Capsule. If the PillSense Capsule did not pass through the GIT, it should be removed by an endoscopic method.

Official Title
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A Clinical Study to Evaluate Effectiveness and Safety of the PillSense System in Detecting Blood in the Stomach for the Evaluation of Upper Gastrointestinal Bleeding (UGIB)

Conditions
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UGI Bleed, Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleed

Intervention / Treatment
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* Diagnostic Test: PillSense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Age >=18 years Ability to provide informed consent Clinical suspicion of UGIB Exclusion Criteria: Circulatory or hemodynamic instability Known GI tract stricture Using an implantable electrical device Difficulties in swallowing pills the size of the capsule History of: achalasia or known esophageal dysmotility; gastroparesis; severe constipation; Crohn's disease; bowel obstruction Currently taking medications intended for stimulation of GI motility Currently pregnant or breastfeeding, or intend to become pregnant during the investigation Suspected or previously diagnosed obstructing gastrointestinal tumor

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PillSense (Active)<br>This is a single-arm, non-randomized study. | Diagnostic Test: PillSense<br>* The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | To assess the sensitivity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either Blood detected or No blood detected. Sensitivity = True Positives / (True Positives + False Negative). True positives were observations of bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False negatives were observation of bleed not detected via capsule but EGD confirmed bleed. | Day 1 | 
| Specificity | To evaluate the specificity of the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either Blood detected or No blood detected. Specificity=True Negatives / (True Negatives + False Positive). True negatives were observations of no bleed detected via PillSense capsule confirmed via esophagogastroduodenoscopy (EGD)]. False positives were observation of bleed detected via capsule but EGD confirmed no bleed. | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NPV | Negative predictive value (NPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either Blood detected or No blood detected. | Day 1 | 
| Transit | To evaluate the transit of the PillSense Capsule through the GI tract. Passage of the capsule will be monitored until capsule has passed from the body. If subject or study team is unable to determine capsule passage visually, a confirmation x-ray or other imaging will be used to determine if the capsule is still present in the body. | Day 1 through Day 14 | 
| PPV | Positive predictive value (PPV) for the PillSense System in detecting the presence of blood in the stomach. The investigational device returns a result of either Blood detected or No blood detected. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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EnteraSense, PillSense, UGI Bleed, UGIB, Upper Gastrointestinal Bleeding, Upper Gastrointestinal Bleed, Upper Gastrointestinal