Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study

NCT05631652 | Completed

• 1 other identifier: CIP-019-02
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.

Conditions

Upper Gastrointestinal Bleeding

Outcome Measures

Primary Outcomes (2)

• Device ability to detect the absence of blood

  Number of subjects in which PillSense capsule was able to identify the absence of blood post capsule ingestion and transmit the results to PillSense Receiver

  within 30 minutes

• Device ability to detect the presence of blood

  Number of subjects in which PillSense Capsule was able to identify the presence of blood post ingestion of a mixture containing autologous blood and transmit the results to PillSense Receiver

  within 30 minutes

Secondary Outcomes (3)

• Ability to ingest the capsule

  within 30 minutes

• Absence of device-related adverse event

  up to 4 weeks

• Absence of device-related adverse event

  up to 4 weeks

Study Arms (1)

PillSense System

EXPERIMENTAL

All subjects were asked to swallow a PillSense Capsule, followed by the ingestion of autologous blood mixed with water, to verify the ability of the PillSense System to correctly identify blood.

Device: PillSense System

Interventions

PillSense System DEVICE

The device is composed of an orally ingested PillSense capsule and a wireless handheld PillSense receiver for real-time display of sensor data. The capsule contains an optical sensor for in-vivo detection of blood. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.

PillSense System

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 -60 years
• Ability to give written informed consent

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
• Presence of pacemaker or other implantable electronic 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)
• Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
• Active psychological issues preventing participation
• Stomach bezoar
• History of severe esophagitis
• History of Crohn disease
• History of diverticulitis
• History of bowel obstruction
• Suspected gastrointestinal tumor disease

Sponsors & Collaborators

• EnteraSense Limited: lead

Study Sites (1)

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: February 11, 2021
• Primary Completion: March 11, 2021
• Study Completion: March 11, 2021
• Last Updated: November 30, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)