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NCT03945500 · ClinicalTrials.gov registry record · NA

Standardized Home Spirometry Method in Normal Population

A NA study, sponsored by Washington University School of Medicine.

Completed
Registry status
NA
Development phase
9
Enrollment target

NCT03945500 is a NA study that has completed, run by Washington University School of Medicine. The registered enrollment target is 9 participants.

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The verdict

NCT03945500, a NA study, has completed, sponsored by Washington University School of Medicine.

COMPLETED
Registry status
NA
Development phase
9 participants
Enrollment target

Study Summary

This study was designed to evaluate the feasibility of using a Standardized Home Spirometry (SHS) Method to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data in normal volunteers prior to evaluation and use on a larger scale for lung transplant recipients. The Standardized Home Spirometry (SHS) Method consists of a FDA-approved Bluetooth Spirometry unit, FDA approved Bluetooth Pulse Oximeter and an Android-based Tablet which is embedded with an investigational Home Spirometry Mobile Medical Software Application for data and symptom survey collection and transmission over secure WiFi or cellular connectivity in HIPAA compliant fashion (labeled only with a date/time and machine ID stamp) to an associated investigational IT Server Dashboard at the Central Monitoring Institute Server at Washington University in St. Louis.

Interventions

  • DEVICE Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2021-01-20
Est. Completion 2022-01-17
Phase NA

What the Registry Record Tells You About NCT03945500

The ClinicalTrials.gov registry entry for NCT03945500 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter is the first listed.

NCT03945500 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03945500 about?

NCT03945500 is a clinical study titled "Standardized Home Spirometry Method in Normal Population". This study was designed to evaluate the feasibility of using a Standardized Home Spirometry (SHS) Method to develop normal range values, to detect a variance (i.e., a value outside of that normal range), to evaluate a variance with a questionnaire, and to download all data in normal volunteers prior...

What is the current status of trial NCT03945500?

This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2021-01-20. Estimated completion is 2022-01-17.

What interventions are being tested in trial NCT03945500?

The interventions under investigation include: Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter (DEVICE).

Who is sponsoring clinical trial NCT03945500?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.