Cryospray Therapy for Benign Airway Stenosis

N/A

Recruiting

Led By Fabien Maldonado, MD

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or symptomatology warranting evaluation

Age > 18

Must not have

Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula

Known or suspected malignant central airway stenosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

Summary

This trial is a prospective, single center, interventional study evaluating the safety and efficacy of SCT in patients with BCAS.

Who is the study for?

This trial is for adults over 18 with significant tracheal stenosis, which means their airway passage is narrowed by at least half. They should be referred for endoscopic treatment of suspected benign tracheal stenosis and able to consent. It's not for those with malignant stenosis, recent multiple treatments, oxygen needs above a certain level, severe lung conditions like COPD or asthma, unstable blood pressure or heart rate, cartilage issues needing surgery or a history of complications from cryotherapy.

What is being tested?

The CryoStasis trial tests spray cryotherapy (SCT), where liquid nitrogen treats the airways versus standard care involving radial incisions and balloon dilation. The goal is to see if SCT can better maintain open airways after six months compared to current methods. This study will provide more solid evidence on whether SCT leads to longer-lasting improvements in patients with non-cancerous narrowing of the breathing tubes.

What are the potential side effects?

While specific side effects are not listed here, procedures like balloon dilation and radial incision can cause bleeding, infection or recurrence of narrowing. Spray cryotherapy may have similar risks along with potential cold-related damage to healthy tissues around the treatment area.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My airway is significantly narrowed by more than half.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I need extra oxygen through a nose tube at 2 liters per minute or more.

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I have a blockage in the airways of my lungs due to cancer.

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I have severe COPD or asthma with significant breathing test abnormalities.

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My airway has a significant weakness needing a stent or surgery, confirmed by a CT scan.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

This trial's timeline: 3 weeks for screening, Varies for treatment, and measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention. for reporting.