Back to resultsDetection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Primary Purpose
Upper Gastrointestinal Bleeding
Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
PillSense System
Sponsored by
About this trial
This is an interventional device feasibility trial for Upper Gastrointestinal Bleeding
Eligibility Criteria
Inclusion Criteria: Age 18 -60 years Ability to give written informed consent Exclusion Criteria: 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 Planned MRI investigation (MRI needed before the capsule is excreted)
Sites / Locations
- Institut klinické a experimentální medicíny (IKEM),
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PillSense System
Arm Description
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.
Outcomes
Primary Outcome Measures
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
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
Secondary Outcome Measures
Ability to ingest the capsule
Number of subjects that were able to ingest the capsule
Absence of device-related adverse event
Number of subject that were able to naturally pass the capsule.
Absence of device-related adverse event
Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction)
Full Information
NCT ID
NCT05631652
First Posted
November 14, 2022
Last Updated
November 21, 2022
Sponsor
EnteraSense Limited
1. Study Identification
Unique Protocol Identification Number
NCT05631652
Brief Title
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Official Title
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
February 11, 2021 (Actual)
Primary Completion Date
March 11, 2021 (Actual)
Study Completion Date
March 11, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EnteraSense Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.
Subjects were followed-up for capsule passing.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Gastrointestinal Bleeding
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PillSense System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PillSense System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Device ability to detect the absence of blood
Description
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
Time Frame
within 30 minutes
Title
Device ability to detect the presence of blood
Description
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
Time Frame
within 30 minutes
Secondary Outcome Measure Information:
Title
Ability to ingest the capsule
Description
Number of subjects that were able to ingest the capsule
Time Frame
within 30 minutes
Title
Absence of device-related adverse event
Description
Number of subject that were able to naturally pass the capsule.
Time Frame
up to 4 weeks
Title
Absence of device-related adverse event
Description
Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction)
Time Frame
up to 4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 18 -60 years
Ability to give written informed consent
Exclusion Criteria:
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
Planned MRI investigation (MRI needed before the capsule is excreted)
Facility Information:
Facility Name
Institut klinické a experimentální medicíny (IKEM),
City
Prague
Country
Czechia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
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