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Evaluation of the Safety and Performance of Centaflow

NCT04438668 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1704

Last updated 2022-06-10

No results posted yet for this study

Summary

The aim of this study is to evaluate the safety and performance of an acoustic approach based on skin-contact microphones as a routine assessment of placental vascular function as predictor of fetal growth restriction.

Conditions

  • Fetal Growth Restriction

Interventions

DEVICE

Centaflow and Standard Care

The intervention is screening methods

DIAGNOSTIC_TEST

Standard Care

The intervention is screening methods

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    collaborator OTHER

  • Viborg Regional Hospital

    collaborator OTHER

  • Centaflow

    lead INDUSTRY

Principal Investigators

  • Richard Farlie, MD, MI, MHM · Viborg Regional Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-06-03
Primary Completion
2022-06-30
Completion
2022-06-30

Countries

  • Denmark

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 NCT04438668 on ClinicalTrials.gov