TruFreeze Cryotherapy Central Airway Disease

Airway Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02572557
• Other study ID #: TruFreeze cryotherapy
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Est. completion date: December 2021

Study information

• Verified date: May 2023
• Source: University Medical Center Groningen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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).

Related Conditions & MeSH terms

• Airway Obstruction

Intervention

Device:
• TruFreeze Spray CryoTherapy
TruFreeze Spray CryoTherapy using liquid nitrogen

Drug:
• Liquid nitrogen
TruFreeze Spray CryoTherapy using liquid nitrogen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Medical Center Groningen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Adverse events during procedure [Safety]	Safety will be assessed by capturing all adverse events (AEs) that occur during the SCT procedure.	During bronchoscopy procedure
Primary	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	Patient reported outcomes [Efficacy]	Efficacy will be measured using patient reported outcomes (questionnaires).	4 weeks follow up
Secondary	Percentage improvement in airway stenosis [Efficacy]	Efficacy will be measured by percentage improvement in airway stenosis.	4 weeks follow up
Secondary	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
Secondary	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

External Links

•   Website of the bronchoscopic intervention center of the UMCG