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

NCT05631639 | Completed

• 1 other identifier: CIP-019-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Device sensitivity

  within 2 hours

• Device Specificity

  within 2 hours

• Safety

  up to 3 weeks

Study Arms (1)

PillSense System

EXPERIMENTAL

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

Interventions

PillSense System DEVICE

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.

PillSense System

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• EnteraSense Limited: lead

Study Sites (3)

Fakultní nemocnice Olomouc (FNOL)

Olomouc, Czechia

Location

Fakultní nemocnice Ostrava (FNO)

Ostrava, Czechia

Location

Institut klinické a experimentální medicíny (IKEM),

Prague, Czechia

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 30, 2022
• Study Start: May 7, 2021
• Primary Completion: June 30, 2021
• Study Completion: August 30, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CZ (3)