A Multi-Center Study of CryoSpray Ablation(tm)in Malignant Airway Disease to Determine, Safety, and Tissue Effect in the Lung (ICE the MAD)
The primary endpoint is efficacy of the cryogen on the tumor evaluated by histopathological
data and visual inspection along with visual confirmation of an absence of scarring and
stricturing of the airway. The primary safety endpoint is the reporting of all adverse
events. The primary symptom measures are the St. Georges Respiratory Questionnaire (SGRQ)
and the Borg Dyspnea Index (BDI).
The secondary endpoint will consist of a measure of treatment efficacy and improvement in
luminal patency assessed by visual inspection. If after the initial repeat bronchoscopy, the
investigator determines that there is no immediate need for further intervention, then any
future bronchoscopy will be performed upon the subject presenting with symptoms.
The proposed study will take place at up to three centers consisting of up to a total of 30
subjects with malignant airway obstruction. Treatment dosimetry will be up to 4, 5-second
spray cycles. Subjects will have initial cryospray treatment at Day 0. Subjects will undergo
repeat bronchoscopy in the first seven days after the initial treatment to check for mucosal
sloughing and to reassess luminal patency of the airway. Subjects may undergo up to one
bronchoscopy with CSA therapy every seven days for a total of four (4) treatments in the
first month. If they present with symptoms thereafter, then a repeat bronchoscopy will be
performed; if luminal obstruction is noted, then the subject will begin the treatment
protocol again. Subjects may also have rigid/flexible bronchoscopy with laser or
electrocautery snare for debulking of tumors. If disease exists bilaterally, only one side
will be sprayed initially.
The study population consists of up to 30 subjects with malignant airway obstruction as a
consequence of an endoluminal tumor that obstructs a portion of the respiratory tree below
the vocal chords. These subjects will have been apprised of Standard of Care options, and
will have rejected those options or have been deemed ineligible for them. Subjects must have
a signed consent form and satisfy all study inclusion and exclusion criteria.
It is estimated that enrollment will take approximately 6 months. Each subject will receive
CryoSpray treatments over the course of 1 year.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy of the cryogen on a tumor evaluated by histopathological data and visual inspection along with visual confirmation of absence of scarring and stricturing of the airway. The primary safety endpoint is the reporting of all adverse events.
William S Krimsky, M.D.
Franklin Square Hospital Center
United States: Institutional Review Board
|Franklin Square Hospital Center||Baltimore, Maryland 21237|
|St. Vincent Medical Center||Los Angeles, California 90025|