TruFreeze Cryotherapy Central Airway Disease

A Prospective Evaluation of Spray Cryotherapy in Patients With Malignant and Benign Central Airway Disease

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.

Study Overview

• Status: Completed
• Conditions: Airway Obstruction
• Intervention / Treatment: Device: TruFreeze Spray CryoTherapy; Drug: Liquid nitrogen

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Spray cryotherapy using liquid nitrogen; Device: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen	Device: TruFreeze Spray CryoTherapy; TruFreeze Spray CryoTherapy using liquid nitrogen; Drug: Liquid nitrogen; TruFreeze Spray CryoTherapy using liquid nitrogen

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of procedures in which SCT was applied as planned [Feasibility]	Feasibility is defined as being able to apply the SCT as planned in one, or more bronchoscopies according to the instructions for use	During bronchoscopy procedure
Adverse events during procedure [Safety]	Safety will be assessed by capturing all adverse events (AEs) that occur during the SCT procedure.	During bronchoscopy procedure
Adverse events during hospital admission [Safety]	Safety will be assessed by capturing all adverse events (AEs) that occur until hospital discharge.	Up to 5 days after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient reported outcomes [Efficacy]	Efficacy will be measured using patient reported outcomes (questionnaires).	4 weeks follow up
Percentage improvement in airway stenosis [Efficacy]	Efficacy will be measured by percentage improvement in airway stenosis.	4 weeks follow up
Time in weeks of durability of initial improvement in airway stenosis[Efficacy]	Efficacy will be measured by durability of treatment effect (time in weeks)	4 weeks follow up
Number of patients with need to re-intervene [Efficacy]	Efficacy will be measured by the need to re-intervene with other therapies because of treatment failure.	4 weeks follow up

Collaborators and Investigators

• Sponsor: University Medical Center Groningen
• Investigators: Principal Investigator: Dirk-Jan Slebos, MD PhD, UMCG

Publications and helpful links

Helpful Links

• Website of the bronchoscopic intervention center of the UMCG

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: October 2, 2015
• First Submitted That Met QC Criteria: October 7, 2015
• First Posted (Estimate): October 9, 2015

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Spray Cryotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency; Airway Obstruction
• Other Study ID Numbers: TruFreeze cryotherapy