PillSense System for Detecting UGI Bleed

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)

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.

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding; Upper Gastrointestinal Bleed; UGI Bleed
• Intervention / Treatment: Diagnostic test: PillSense

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 131
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: EnteraSense Limited
• Collaborators: Databean
• Investigators: Study Director: David Collins, Technical Operations Director

Study record dates

Study Major Dates

• Study Start (Actual): December 10, 2021
• Primary Completion (Actual): September 7, 2022
• Study Completion (Actual): September 13, 2022

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: May 18, 2022
• First Posted (Actual): May 23, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Upper Gastrointestinal Bleeding; UGIB; EnteraSense; PillSense; UGI Bleed; Upper Gastrointestinal Bleed; Upper Gastrointestinal
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: CIP-019-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No