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TruFreeze™ Airway Obstruction: TAO STUDY

NCT01903850 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2016-02-02

No results posted yet for this study

Summary

The purpose of this study is to prospectively assess the efficacy and safety of spray cryotherapy ablation with the truFreeze System in conjunction with mechanical dilation or debridement for the treatment of clinically significant obstructions of the central airways. The primary effectiveness endpoint is the proportion of subjects with a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention 30 days (+/- 5 days) following treatment. Additionally, a primary clinical safety endpoint is the reporting of all adverse events.

Conditions

  • Lung Disease Airways
  • Lung Diseases, Obstructive
  • Airway; Obstruction, With Emphysema
  • Airway Obstruction

Interventions

DEVICE

spray cryotherapy

spray cryotherapy

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Hiran C Fernando, MD · Boston Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-05-31
Completion
2014-09-30

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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 NCT01903850 on ClinicalTrials.gov