Clinical Trial: TruFreeze™ Airway Obstruction: TAO STUDY

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: A PROSPECTIVE, MULTI-CENTER PILOT STUDY OF THE truFREEZE™ SYSTEM TO ASSESS THE EFFICACY AND SAFETY OF CRYO SPRAY ABLATION IN THE TREATMENT OF AIRWAY OBSTRUCTIONS (Tr

Brief 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.

Detailed Summary:

This multi-center prospective feasibility study will enroll at up to 6 clinical sites for a total of 30 subjects. Enrollment criteria includes subjects with clinically significant benign or malignant obstructions of the central airways, who require treatment intervention and are not candidates for surgical resection. The central airways are defined as including the trachea, left or right main bronchus, or the bronchus intermedius on the right. Spray cryotherapy (SCT) using the truFreeze system will be used in conjunction with mechanical interventions (balloon/rigid dilation or debridement of tumors) to improve airway patency. Subjects will receive up to 4, 5-second spray cycles prior to mechanical intervention (balloon/rigid dilation or debridement of tumors), followed by up to 4, 5-second additional spray cycles immediately following mechanical intervention.

The degree of airway narrowing will be estimated by the treating physicians before and after each treatment using a graded scale. Digital endoscopic images of each obstruction taken before and after each treatment, will also be assessed by a neutral assessor blinded to treatment. Subjects will be contacted on Day 1 following treatment to assess for any treatment related adverse events. Subjects may undergo a repeat bronchoscopy two weeks (14 days +/- 2 days) following the initial SCT treatment if clinically indicated or routine practice of the treating physician. A SCT treatment at a NORMAL flow setting may be performed at the 14 day bronchoscopy if deemed clinically indicated. If subjects are treated with SCT at the 14-day treatment, they will again be contacted on Day 1 following treatment to assess for any treatment related adverse events.

A follow-up bronchoscopy to reassess luminal patency and treatment site healing response will be performed at 30 days (+/- 5 da
Sponsor: CSA Medical, Inc.

Current Primary Outcome: The primary clinical effectiveness endpoint is a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention, on the Day 30 assessment following the last SCT treatment. [ Time Frame: 30 - 44 Days (+/- 5 days) ]

The primary efficacy endpoint for statistical analysis and study powering is the proportion of subjects exhibiting an adequate (minimum of 25%) improvement in airway patency on the Day 30 assessment following the last SCT treatment.


Original Primary Outcome:

  • The primary clinical effectiveness endpoint is a minimum of 25% improvement in luminal patency following SCT treatment and mechanical intervention, on the Day 30 assessment following the last SCT treatment. [ Time Frame: 30 - 44 Days (+/- 5 days) ]
    The primary efficacy endpoint for statistical analysis and study powering is the proportion of subjects exhibiting an adequate (minimum of 25%) improvement in airway patency on the Day 30 assessment following the last SCT treatment.
  • Clinical Safety Endpoint [ Time Frame: 30-44 days (+/- 5 days) ]
    Primary clinical safety endpoint is the reporting of all adverse events.


Current Secondary Outcome: Subject symptoms and functional status [ Time Frame: 30-44 days (+/- 5 days) ]

Secondary endpoint will consist of a measure of changes in subject symptoms and functional status prior to and 30 days (+/- 5 days)


Original Secondary Outcome: Same as current

Information By: CSA Medical, Inc.

Dates:
Date Received: July 16, 2013
Date Started: July 2013
Date Completion:
Last Updated: February 1, 2016
Last Verified: February 2016