TruFreeze Cryotherapy Central Airway Disease

NCT02572557 | Completed DMC

• 1 other identifier: TruFreeze cryotherapy
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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. 1.To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
2. 2.To investigate the safety of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
3. 3.To investigate the efficacy of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.

Conditions

Airway Obstruction

Keywords

Spray Cryotherapy

Outcome Measures

Primary Outcomes (3)

• 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

• Adverse events during procedure [Safety]

  Safety will be assessed by capturing all adverse events (AEs) that occur during the SCT procedure.

  During bronchoscopy procedure

• 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 Outcomes (4)

• Patient reported outcomes [Efficacy]

  4 weeks follow up

• Percentage improvement in airway stenosis [Efficacy]

  4 weeks follow up

• Time in weeks of durability of initial improvement in airway stenosis[Efficacy]

  4 weeks follow up

• Number of patients with need to re-intervene [Efficacy]

  4 weeks follow up

Study Arms (1)

Spray cryotherapy using liquid nitrogen

EXPERIMENTAL

Device: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen

Device: TruFreeze Spray CryoTherapy; Drug: Liquid nitrogen

Interventions

TruFreeze Spray CryoTherapy DEVICE

TruFreeze Spray CryoTherapy using liquid nitrogen

Spray cryotherapy using liquid nitrogen

Liquid nitrogen DRUG

TruFreeze Spray CryoTherapy using liquid nitrogen

Spray cryotherapy using liquid nitrogen

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patient has an inability to tolerate bronchoscopy under general anaesthesia.
• 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).
• Airway diameter causing an anatomical flow resistance inhibiting N2 gas evacuation (Endotracheal tube or equivalent \<8.5mm will be excluded).

Sponsors & Collaborators

• University Medical Center Groningen: lead

Related Links

• Website of the bronchoscopic intervention center of the UMCG

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Dirk-Jan Slebos, MD PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: October 9, 2015
• Study Start: December 1, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 11, 2023

Record last verified: 2023-05