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TruFreeze Cryotherapy Central Airway Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02572557
Recruitment Status : Enrolling by invitation
First Posted : October 9, 2015
Last Update Posted : March 24, 2020
Sponsor:
Information provided by (Responsible Party):
Dirk-Jan Slebos, University Medical Center Groningen

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.


Condition or disease Intervention/treatment Phase
Airway Obstruction Device: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Evaluation of Spray Cryotherapy in Patients With Malignant and Benign Central Airway Disease
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Choking

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




Primary Outcome Measures :
  1. 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

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Patient reported outcomes [Efficacy] [ Time Frame: 4 weeks follow up ]
    Efficacy will be measured using patient reported outcomes (questionnaires).

  2. Percentage improvement in airway stenosis [Efficacy] [ Time Frame: 4 weeks follow up ]
    Efficacy will be measured by percentage improvement in airway stenosis.

  3. 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)

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02572557


Sponsors and Collaborators
University Medical Center Groningen
Investigators
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Principal Investigator: Dirk-Jan Slebos, MD PhD UMCG
Additional Information:
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Responsible Party: Dirk-Jan Slebos, MD PhD, University Medical Center Groningen
ClinicalTrials.gov Identifier: NCT02572557    
Other Study ID Numbers: TruFreeze cryotherapy
First Posted: October 9, 2015    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Keywords provided by Dirk-Jan Slebos, University Medical Center Groningen:
Spray Cryotherapy
Additional relevant MeSH terms:
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Airway Obstruction
Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases