TruFreeze Cryotherapy Central Airway Disease

NCT ID: NCT02572557

Last Updated: 2023-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-12-31
• Study Completion Date: 2021-12-31

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.

Conditions

Airway Obstruction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Spray cryotherapy using liquid nitrogen

Device: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen

Group Type: EXPERIMENTAL

TruFreeze Spray CryoTherapy

Intervention Type: DEVICE

TruFreeze Spray CryoTherapy using liquid nitrogen

Liquid nitrogen

Intervention Type: DRUG

TruFreeze Spray CryoTherapy using liquid nitrogen

Interventions

TruFreeze Spray CryoTherapy

TruFreeze Spray CryoTherapy using liquid nitrogen

Intervention Type: DEVICE

Liquid nitrogen

TruFreeze Spray CryoTherapy using liquid nitrogen

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

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).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Dirk-Jan Slebos

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dirk-Jan Slebos, MD PhD

Role: PRINCIPAL_INVESTIGATOR

UMCG

Related Links

http://www.bicumcg.nl

Website of the bronchoscopic intervention center of the UMCG

Other Identifiers

TruFreeze cryotherapy

Identifier Type: -

Identifier Source: org_study_id