Lung Diseases, Obstructive Clinical Trial
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)
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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