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Carbon Monoxide Measurement to Screen for Sickle Cell Disease

NCT02530242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2021-06-09

Study results available
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Summary

Modify the design of the CoSense device (Model C20112, currently cleared by the FDA for ETCO (end-tidal carbon monoxide) monitoring to improve accuracy and consistency under temperature conditions encountered in countries with high prevalence of SCD (Sickle Cell Disease).

Conditions

Interventions

DEVICE

End-tidal Carbon Monoxide Subjects

ETCO monitor will be used to measure CO levels in subjects and controls.

DEVICE

End-tidal Carbon Monoxide Controls

ETCO monitor will be used to measure CO levels in subjects and controls.

Sponsors & Collaborators

  • Capnia, Inc.

    collaborator INDUSTRY

  • UCSF Benioff Children's Hospital Oakland

    lead OTHER

Principal Investigators

  • Ashutosh Lal, MD · Children's Hospital & Research Center at Oakland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2015-10-31
Completion
2015-12-31

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Entities

Diseases

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 NCT02530242 on ClinicalTrials.gov