TruFreeze Cryotherapy Central Airway Disease

Status Completed

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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Airway Obstruction

Clinical Trial Details

NCT number	NCT02572557
Study type	Interventional
Source	University Medical Center Groningen
Contact
Status	Completed
Phase	N/A
Start date	December 2016
Completion date	December 2021

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.