Airway ObstructionNCT02572557
TruFreeze Cryotherapy Central Airway Disease
A study testing TruFreeze Spray CryoTherapy and Liquid nitrogen in people with Airway Obstruction, run by University Medical Center Groningen.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Airway Obstruction
- What is being tested?
- TruFreeze Spray CryoTherapy and Liquid nitrogen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Presence of malignant or benign central airway disease where current treatment options are regarded to be suboptimal.
Who cannot join
- 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).
About this study
Official title: A Prospective Evaluation of Spray Cryotherapy in Patients With Malignant and Benign Central Airway Disease
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:
Read more
- To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
- To investigate the safety of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
- 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
- Being tested
- TruFreeze Spray CryoTherapy, Liquid nitrogen
- Keywords
- Spray Cryotherapy
- Medical subject headings
- Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruFreeze Spray CryoTherapyDevice
TruFreeze Spray CryoTherapy using liquid nitrogen
Liquid nitrogenDrug
TruFreeze Spray CryoTherapy using liquid nitrogen
| Study group | Role | What they receive |
|---|---|---|
| Spray cryotherapy using liquid nitrogen | Experimental | Device: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen Receives: Device: TruFreeze Spray CryoTherapy; Drug: Liquid nitrogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During bronchoscopy procedure
Adverse events during procedure [Safety]
Safety will be assessed by capturing all adverse events (AEs) that occur during the SCT procedure.
Measured: During bronchoscopy procedure
Adverse events during hospital admission [Safety]
Safety will be assessed by capturing all adverse events (AEs) that occur until hospital discharge.
Measured: Up to 5 days after treatment
Secondary outcomes (4)
Patient reported outcomes [Efficacy]
Efficacy will be measured using patient reported outcomes (questionnaires).
Measured: 4 weeks follow up
Percentage improvement in airway stenosis [Efficacy]
Efficacy will be measured by percentage improvement in airway stenosis.
Measured: 4 weeks follow up
Time in weeks of durability of initial improvement in airway stenosis[Efficacy]
Efficacy will be measured by durability of treatment effect (time in weeks)
Measured: 4 weeks follow up
Number of patients with need to re-intervene [Efficacy]
Efficacy will be measured by the need to re-intervene with other therapies because of treatment failure.
Measured: 4 weeks follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startDec 2016
- Primary completionDec 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ObstructionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk-Jan Slebos, University Medical Center Groningen
- Investigators
- Dirk-Jan Slebos, MD PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572557
- Sponsor's protocol ID
- TruFreeze cryotherapy
- Status last verified
- May 2023
- First submitted
- 2 Oct 2015
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Evaluation of Spray Cryotherapy in Patients With Malignant and Benign Central Airway Disease
- ClinicalTrials.gov ID
- NCT02572557
- Acronym / sponsor ID
- TruFreeze cryotherapy
- Conditions
- Airway Obstruction
- Keywords
- Spray Cryotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 9 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To investigate the feasibility of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
- To investigate the safety of using Spray cryotherapy (SCT) for the treatment of malignant and benign central airway disease.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spray cryotherapy using liquid nitrogen | Experimental | Device: TruFreeze Spray CryoTherapy, Drug: Liquid nitrogenDevice: TruFreeze Spray CryoTherapy Drug: Liquid nitrogen |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Presence of malignant or benign central airway disease where current treatment options are regarded to be suboptimal.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TruFreeze Spray CryoTherapyTruFreeze Spray CryoTherapy using liquid nitrogen | Device | Spray cryotherapy using liquid nitrogen |
| Liquid nitrogenTruFreeze Spray CryoTherapy using liquid nitrogen | Drug | Spray cryotherapy using liquid nitrogen |
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.
4 secondary outcomes
Patient reported outcomes [Efficacy]
Time frame: 4 weeks follow up
Percentage improvement in airway stenosis [Efficacy]
Time frame: 4 weeks follow up
Time in weeks of durability of initial improvement in airway stenosis[Efficacy]
Time frame: 4 weeks follow up
Number of patients with need to re-intervene [Efficacy]
Time frame: 4 weeks follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Website of the bronchoscopic intervention center of the UMCGLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dirk-Jan Slebos, MD PhD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing TruFreeze Spray CryoTherapy and Liquid nitrogen in people with Airway Obstruction, run by University Medical Center Groningen.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of procedures in which SCT was applied as planned [Feasibility] (time frame: During bronchoscopy procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.