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Assessment of the Pivot Breath Sensor: Single-Arm Cohort Study

NCT04133064 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 234

Last updated 2022-11-09

Study results available
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Summary

Prospective open label, single center study enrolling up to 220 participants to evaluate the effect of the Pivot Breath Sensor on a user's attitudes towards quitting smoking and smoking behavior.

Conditions

  • Smoking Reduction
  • Smoking Behaviors
  • Smoking, Tobacco
  • Smoking Cessation

Interventions

DEVICE

Pivot Breath Sensor

The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.

Sponsors & Collaborators

  • Jennifer Marler, MD

    lead INDUSTRY

Principal Investigators

  • Jen Marler · Pivot Health Technologies Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-25
Primary Completion
2020-03-10
Completion
2020-10-01
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 NCT04133064 on ClinicalTrials.gov