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 range18 Years

SexALL

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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)

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