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New treatment option for Stenosis Trachea
Official title Cryospray Therapy for Benign Airway Stenosis
ClinicalTrials.gov ID: NCT06085209
What this study is testing
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Referral to treatment pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- Able to provide informed consent.
- Age \> 18
You likely can't join if
- Inability to provide informed consent
- Pregnancy
- Known or suspected malignant central airway stenosis
- Patient has already been enrolled in this study.
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
See the full eligibility criteria
- Referral to treatment pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- Able to provide informed consent.
- Age \> 18
- Inability to provide informed consent
- Pregnancy
- Known or suspected malignant central airway stenosis
- Patient has already been enrolled in this study.
- Study subject has any disease or condition that interferes with safe completion of the study including:
- 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 \ 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)
- Prior complications with SCT (Spray cryotherapy)
- Contraindication to rigid bronchoscopy
- Significant tracheomalacia or alterations in cartilage integrity on CT (Computed Tomography) that would require stent placement or surgical referral.
- Greater than 1 BCAS intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment.
- Anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from...
The study team makes the final eligibility decision.
Where it's taking place
- Richmond, Virginia, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Richmond, Virginia, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.