Genesis Electrical Impedance Tomography (EIT): A Preliminary Study

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03797183
Status
Recruiting
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Conditions

  • Bronchopulmonary Dysplasia
  • Chronic Respiratory Disease
  • Healthy
  • Neuromuscular Diseases
  • Premature Infant
  • Pulmonary Vein Stenoses

Eligibility Criteria

Sex
ALL
Age
14 Days - 40 Years
Healthy Volunteers
Accepted

Study Details

The purpose of this study is to evaluate the Genesis Electrical Impedance Tomography (EIT) imaging system for use in pediatric respiratory disease populations including neuromuscular and bronchopulmonary dysplasia, as well as in age and height matched controls. The EIT does not use radiation, and is read through electrodes.

Key Dates

Start date
May 3, 2019
Status verified
Nov 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2026

Study Design

Enrollment
90 participants (estimated)

Arms

  • Arm: Premature Infants
    Premature infants \>1 month of age currently hospitalized with bronchopulmonary dysplasia (BPD) without acute respiratory infection
  • Arm: Chronic Respiratory Disease
    Participants ages \>1 month-21 years with chronic respiratory disease due to underlying neuromuscular disease
  • Arm: Neuromuscular Disease
    Participants ages 21-40 years with confirmed neuromuscular disease with an echo completed within the preceding 12 months of study participation of Duchenne muscular dystrophy (DMD) or other diagnoses associated with mild cardiomyopathy
  • Arm: Healthy Controls
    Age and height matched healthy controls
  • Arm: V/Q Scan validation
    Adults or children who are having or have recently had a V/Q scan
  • Arm: Premature Infants (Longitudinal Cohort)
    Premature infants ages 2 weeks to 1 year with diagnosed or suspected bronchopulmonary dysplasia
  • Arm: Pulmonary Vein/Artery Stenosis
    Children age 2 months to 18 years, who will be undergoing cardiac catheterization for pulmonary vein stenosis, pulmonary hypertension and/or pulmonary artery stenosis

Primary Outcome Measure

EIT imaging maps that provide regional information regarding ventilation and perfusion of the lung. [ Time Frame: 24 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital ColoradoAuroraColorado80045
Emily DeBoer, MD
[email protected]
720-777-4953
Allison Keck
[email protected]
720-777-0734

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By research site
Children's Hospital Colorado· Aurora, CO

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