Rationale: Spray cryotherapy (SCT) using liquid nitrogen has been safely and effectively used
in the esophagus, airways and pleura. Treatment with SCT for central airway stenosis may
provide an effective, and more durable and perhaps safer alternative to the current
therapeutic modalities.
Objectives:
1. To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of
malignant and benign central airway disease.
2. To investigate the safety of using Spray cryotherapy (SCT) for the treatment of
malignant and benign central airway disease.
3. To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of
malignant and benign central airway disease.
Study design: This study will be a prospective, single arm, open label intervention study
performed at the University Medical Center Groningen, The Netherlands Study population: The
study population exists of 25 patients with malignant or benign central airway disease.
Patients in which current treatment options are regarded to be suboptimal can be included in
the study.
Intervention: TruFreeze Spray CryoTherapy
Main study parameter:
Feasibility is defined as being able to apply the SCT as planned in one, or more
bronchoscopies according to the instructions for use (IFU).
Secondary study parameters:
Safety will be assessed by capturing all adverse events (AEs) that occur 1) during the SCT
procedure, and 2) all AEs that occur until hospital discharge.
Efficacy will be measured using 1) patient reported outcomes (questionnaires), 2) percentage
improvement in airway stenosis, 3) durability of treatment effect, 4) need to re-intervene
with other therapies because of treatment failure.
Nature and extent of the burden, risks and benefit associated with participation.
Patients that will be recruited and participate in this prospective clinical trial have a
severe central airway disease which is highly symptomatic for which current available
therapies are either very difficult to perform, are hazardous, have no real benefit, or just
simply not available yet. The current treatment risks of this patient group are high,
especially in the patients where the airway patency is at risk. The main additional risk
associated with the use of SCT is the occurrence of a pneumothorax. Patients participating
will adhere to their current medical care, with the one addition of a voluntary follow-up
bronchoscopy after SCT.