TruFreeze™ Airway Obstruction: TAO STUDY (TAO)
|ClinicalTrials.gov Identifier: NCT01903850|
Recruitment Status : Withdrawn (Withdrawn for business reasons)
First Posted : July 19, 2013
Last Update Posted : February 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Lung Disease Airways Lung Diseases, Obstructive Airway; Obstruction, With Emphysema Airway Obstruction||Device: spray cryotherapy||Phase 4|
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 days) following the last SCT treatment. The last SCT treatment may be the initial treatment day or 14-day treatment if performed. again, the degree of airway narrowing will be estimated by the treating physicians using a graded scale and digital endoscopic images of each obstruction will be taken to be assessed by a neutral assessor blinded to treatment.
The primary efficacy endpoint for statistical analysis and study powering will be the proportion of subjects exhibiting an adequate (minimum of 25%) improvement in airway patency. Based on prior clinical experience with liquid nitrogen spray cryotherapy and other ablation techniques, a response rate of approximately 80% is anticipated. This study is powered to detect a 20% lower response rate (i.e. 60% or lower) compared to the expected rate.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 (TruFreeze AIRWAY OBSTRUCTION - "TAO" STUDY)|
|Study Start Date :||July 2013|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||September 2014|
Experimental: spray cryotherapy
spray cryotherapy: 4 -5 second sprays at Baseline (possible additional tx. to be determined at follow up)
Device: spray cryotherapy
Other Name: truFreeze™ Spray cryotherapy
- 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.
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01903850
|Principal Investigator:||Hiran C Fernando, MD||Boston Medical Center|