Clinical trial NCT02572557: TruFreeze Cryotherapy Central Airway Disease
Official title: A Prospective Evaluation of Spray Cryotherapy in Patients With Malignant and Benign Central Airway Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Obstruction
Keywords: Spray Cryotherapy
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
First posted: 2015-10-09
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criterium:

1. Presence of malignant or benign central airway disease where current treatment options are regarded to be suboptimal.

Exclusion Criteria:

1. Patient has an inability to tolerate bronchoscopy under general anaesthesia.
2. Compromised tissue (significant ulceration or mucosal break in the ablation area, any procedure or pre-existing condition has significantly reduced tissue strength or has significantly reduced the elasticity of the ablation area).
3. Airway diameter causing an anatomical flow resistance inhibiting N2 gas evacuation (Endotracheal tube or equivalent \<8.5mm will be excluded).

Primary outcomes:
measure: Number of procedures in which SCT was applied as planned [Feasibility]
timeFrame: During bronchoscopy procedure
measure: Adverse events during procedure [Safety]
timeFrame: During bronchoscopy procedure
measure: Adverse events during hospital admission [Safety]
timeFrame: Up to 5 days after treatment
Secondary outcomes:
measure: Patient reported outcomes [Efficacy]
timeFrame: 4 weeks follow up
measure: Percentage improvement in airway stenosis [Efficacy]
timeFrame: 4 weeks follow up
measure: Time in weeks of durability of initial improvement in airway stenosis[Efficacy]
timeFrame: 4 weeks follow up
measure: Number of patients with need to re-intervene [Efficacy]
timeFrame: 4 weeks follow up
Other outcomes:
Locations:
Study officials:
affiliation: UMCG
name: Dirk-Jan Slebos, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: