Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

Upper Gastrointestinal Bleeding Clinical Trial

Official title:

Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05631639
• Other study ID #: CIP-019-01
• Status: Completed
• Phase: N/A
• Start date: May 7, 2021
• Est. completion date: August 30, 2021

Study information

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

Clinical Trial Summary

This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).

Description:

The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".

All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".

The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age 18 -80 years

• Ability to give written informed consent

• Clinical suspicion of bleeding

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. Subject is using a pacemaker or other implantable electrical 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. Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation

9. Presence of psychological issues preventing participation

10. Stomach bezoar

11. History of Crohn disease

12. History of diverticulitis

13. History of bowel obstruction

14. Suspected gastrointestinal tumor disease

15. 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 PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display.

Locations

Country	Name	City	State
Czechia	Fakultní nemocnice Olomouc (FNOL)	Olomouc
Czechia	Fakultní nemocnice Ostrava (FNO)	Ostrava
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 feasibility	Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver	within 30 minutes
Secondary	Device sensitivity	Subjects with positive findings for blood based on PillSense and EGD	within 2 hours
Secondary	Device Specificity	Subjects with negative findings for blood based on PillSense and EGD	within 2 hours
Secondary	Safety	Number of patients that developed device-related adverse event (etc. retention, aspiration or bowel obstruction)	up to 3 weeks