Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).

Study Overview

• Status: Completed
• Conditions: Upper Gastrointestinal Bleeding
• Intervention / Treatment: Device: PillSense System

Detailed Description

The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".

All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".

The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Olomouc, Czechia
    • Fakultni Nemocnice Olomouc (FNOL)
  • Ostrava, Czechia
    • Fakultni Nemocnice Ostrava (FNO)
  • Prague, Czechia
    • Institut klinické a experimentální medicíny (IKEM),

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 -80 years
• Ability to give written informed consent
• Clinical suspicion of bleeding

Exclusion Criteria:

1. Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)
2. Known current stenosis of the GI tract
3. Subject is using a pacemaker or other implantable electrical device
4. Dysphagia or difficulties in swallowing pills the size of the capsule
5. History of achalasia or known esophageal dysmotility
6. History of gastroparesis
7. History of severe constipation (1 bowel movement per week or less)
8. Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
9. Presence of psychological issues preventing participation
10. Stomach bezoar
11. History of Crohn disease
12. History of diverticulitis
13. History of bowel obstruction
14. Suspected gastrointestinal tumor disease
15. Planned MRI investigation (MRI needed before the capsule is excreted)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• 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 System; The device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.	Device: PillSense System; The PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device feasibility	Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver	within 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device sensitivity	Subjects with positive findings for blood based on PillSense and EGD	within 2 hours
Device Specificity	Subjects with negative findings for blood based on PillSense and EGD	within 2 hours
Safety	Number of patients that developed device-related adverse event (etc. retention, aspiration or bowel obstruction)	up to 3 weeks

Collaborators and Investigators

• Sponsor: EnteraSense Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2021
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): November 30, 2022

Study Record Updates

• Last Update Posted (Actual): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 21, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Hemorrhage; Gastrointestinal Hemorrhage
• Other Study ID Numbers: CIP-019-01

Drug and device information, study documents

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