Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Upper Gastrointestinal Bleeding
- Sponsor
- EnteraSense Limited
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Device ability to detect the absence of blood
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Device ability to detect the absence of blood
Time Frame: within 30 minutes
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
Time Frame: within 30 minutes
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 Outcomes
- Ability to ingest the capsule(within 30 minutes)
- Absence of device-related adverse event(up to 4 weeks)