RecruitingPhase 1

Cryospray Therapy for Benign Airway Stenosis

United States12 participantsStarted 2023-10-12

Plain-language summary

This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
. Pneumothorax in the previous 12 months
. Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \<30% predicted) and/or severe persistent asthma.
. Hemodynamic instability with systolic blood pressure \<90 mmHg or heart rate \> 120 beats/min, unless deemed to be stable with these values by the attending physicians.
. Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
. Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
. Significantly reduced elasticity of the ablation area (e.g. Marfan's Syndrome)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Degree of re-stenosis

Timeframe: 6 months

Trial details

NCT IDNCT06085209

SponsorVirginia Commonwealth University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-12-30

Contact for this trial

Ramsha Hamid

(804) 628-2176 ramsha.hamid@vcuhealth.org

View on ClinicalTrials.gov More Stenosis Trachea trials