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

NCT ID: NCT05631639

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-07

Study Completion Date

2021-08-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Upper Gastrointestinal Bleeding

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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PillSense System

The device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.

Group Type EXPERIMENTAL

PillSense System

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EnteraSense Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fakultní nemocnice Olomouc (FNOL)

Olomouc, , Czechia

Site Status

Fakultní nemocnice Ostrava (FNO)

Ostrava, , Czechia

Site Status

Institut klinické a experimentální medicíny (IKEM),

Prague, , Czechia

Site Status

Countries

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Czechia

Other Identifiers

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CIP-019-01

Identifier Type: -

Identifier Source: org_study_id