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Procedure

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

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.

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percent change in radiographic airway lumen volume at 6 months by CT

Secondary outcome measures

Change in peak expiratory flow (PEF)

Change in quality of life using the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (COPD CCQ)

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: InterventionActive Control3 Interventions

Bronchoscopic Balloon Dilation with Radial Cuts & truFreeze Spray Cryotherapy

Group II: ControlPlacebo Group2 Interventions

Bronchoscopic Balloon Dilation with Radial Cuts

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityOTHER

698 Previous Clinical Trials

22,884,955 Total Patients Enrolled

University of Mississippi Medical CenterOTHER

173 Previous Clinical Trials

195,047 Total Patients Enrolled

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

672,152 Total Patients Enrolled

Media Library

Spray cryotherapy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04996173 — N/A

Lung Disease Research Study Groups: Control, Intervention

Lung Disease Clinical Trial 2023: Spray cryotherapy Highlights & Side Effects. Trial Name: NCT04996173 — N/A

Spray cryotherapy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04996173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants has the maximum capacity of this experiment been set to?

"Affirmative. According to clinicaltrials.gov, this experiment is currently accepting participants. It was originally posted on October 25th 2021 and has since been edited on March 18th 2022. 40 individuals are needed from one site for the study's completion."

Answered by AI

Is there an open enrollment period for this research endeavor?

"Per clinicaltrials.gov, this study is actively recruiting patients and was initially posted on October 25th 2021 with the most recent edit occurring on March 18th 2022."

Answered by AI

Who else is applying?

What site did they apply to?

Vanderbilt University Medical Center

What portion of applicants met pre-screening criteria?

Did not meet criteria

Why did patients apply to this trial?

I am looking to see if there are alternatives to the dilation surgery. My condition is stable since it was diagnosed in March of 2022. However, it is only a matter of time before surgery will be needed. I know the surgery is ongoing and that many people have had multiple surgeries every year. I am looking for a less invasive and/or better treatment option.

PatientReceived no prior treatments

Recent research and studies

clinicaltrials.govStudy

Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

Ankush Ratwani 2021. "Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04996173.

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