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

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631652
• Other study ID #: CIP-019-02
• Status: Completed
• Phase: N/A
• Start date: February 11, 2021
• Est. completion date: March 11, 2021

Study information

• Verified date: November 2022
• Source: EnteraSense Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 11, 2021
• Est. primary completion date: March 11, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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)

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage
• Hemorrhage
• Upper Gastrointestinal Bleeding

Intervention

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.

Locations

Country	Name	City	State
Czechia	Institut klinické a experimentální medicíny (IKEM),	Prague

Sponsors (1)

Lead Sponsor	Collaborator
EnteraSense Limited

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Ability to ingest the capsule	Number of subjects that were able to ingest the capsule	within 30 minutes
Secondary	Absence of device-related adverse event	Number of subject that were able to naturally pass the capsule.	up to 4 weeks
Secondary	Absence of device-related adverse event	Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction)	up to 4 weeks