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

• Sponsor: EnteraSense Limited (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05631652
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Days): 28
• Patients Per Site Per Month: 10.9

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Upper Gastrointestinal Bleeding	Device: PillSense System	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
• Actual Study Start Date: Feb 11, 2021
• Actual Primary Completion Date: Mar 11, 2021
• Actual Study Completion Date: Mar 11, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PillSense System 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; 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.

Outcome Measures

Primary Outcome Measures

1. Device ability to detect the absence of blood [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

2. Device ability to detect the presence of blood [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 Outcome Measures

1. Ability to ingest the capsule [within 30 minutes]

   Number of subjects that were able to ingest the capsule

2. Absence of device-related adverse event [up to 4 weeks]

   Number of subject that were able to naturally pass the capsule.

3. Absence of device-related adverse event [up to 4 weeks]

   Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Age 18 -60 years

2. Ability to give written informed consent

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. Presence of pacemaker or other implantable electronic 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. Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation

9. Active psychological issues preventing participation

10. Stomach bezoar

11. History of severe esophagitis

12. History of Crohn disease

13. History of diverticulitis

14. History of bowel obstruction

15. Suspected gastrointestinal tumor disease

16. Planned MRI investigation (MRI needed before the capsule is excreted)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Institut klinické a experimentální medicíny (IKEM),	Prague		Czechia

Sponsors and Collaborators

• EnteraSense Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EnteraSense Limited
• ClinicalTrials.gov Identifier: NCT05631652
• Other Study ID Numbers: CIP-019-02
• First Posted: Nov 30, 2022
• Last Update Posted: Nov 30, 2022
• Last Verified: Nov 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gastrointestinal Hemorrhage; Hemorrhage

Study Results

No Results Posted as of Nov 30, 2022