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PillSense System for Detecting UGI Bleed

NCT05385224 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2023-10-26

Study results available
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Summary

This is a prospective, non-randomized, open-label clinical investigation to evaluate feasibility, effectiveness and safety of the PillSense System, the transit of the PillSense Capsule through the GI tract, patient tolerability of the PillSense Capsule, and blood detection.

Conditions

  • UGI Bleed
  • Upper Gastrointestinal Bleeding
  • Upper Gastrointestinal Bleed

Interventions

DIAGNOSTIC_TEST

PillSense

The PillSense System is intended to detect the presence of blood in the stomach for the evaluation of upper gastrointestinal bleeding.

Sponsors & Collaborators

  • Databean

    collaborator INDUSTRY

  • EnteraSense Limited

    lead INDUSTRY

Principal Investigators

  • David Collins · Technical Operations Director

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-10
Primary Completion
2022-09-07
Completion
2022-09-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05385224 on ClinicalTrials.gov