Clinical Trial: TruFreeze Cryotherapy Central Airway Disease

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: University Medical Center Groningen

Current Primary Outcome:

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

Original Primary Outcome:

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

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: University Medical Center Groningen

Dates:
Date Received: October 2, 2015
Date Started: October 2016
Date Completion: December 2017
Last Updated: June 17, 2016
Last Verified: June 2016