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Cryospray Therapy for Airway Stenosis (CRYOSTASIS Trial)

Phase 1

Recruiting

Led By Ray Shepherd

Research Sponsored by Virginia Commonwealth University

Eligibility Criteria Checklist

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

Must have

Age > 18

Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,

Awards & highlights

CRYOSTASIS Trial Summary

This trial assesses if cryospray therapy improves treatment for airway stenosis, with results estimated by 6-month follow-up radiologic assessment.

Who is the study for?

Adults over 18 with severe tracheal narrowing (at least half blocked) as seen on a chest CT or bronchoscopy, who are referred for endoscopic treatment of non-cancerous airway tightening. Not for pregnant individuals, those with recent pneumothorax, severe lung conditions, unstable blood pressure or heart rate, prior negative reactions to cryospray therapy, or certain anatomical issues.Check my eligibility

What is being tested?

The trial is testing if adding Cryospray Therapy (SCT) to standard balloon dilation and radial incision treatments can better prevent the return of benign airway constriction within six months. Participants' airways will be measured using radiology to see if SCT makes a difference.See study design

What are the potential side effects?

Potential side effects may include discomfort at the treatment site, risk of tissue damage due to freezing temperatures from cryotherapy, breathing difficulties post-procedure, and possible complications from undergoing rigid bronchoscopy.

CRYOSTASIS Trial Eligibility Criteria

Inclusion Criteria

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

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I am older than 18 years.

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My airway is significantly narrowed by more than half.

CRYOSTASIS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark, for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Degree of re-stenosis

Secondary outcome measures

Change in Peak Expiratory Flow (PEF)

Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)

Incidence of complications between groups

CRYOSTASIS Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: InterventionExperimental Treatment3 Interventions

Bronchoscopic balloon dilation with radial cuts & truFreeze spray cryotherapy

Group II: Standard of careActive Control2 Interventions

Bronchoscopic balloon dilation with radial cuts

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor

699 Previous Clinical Trials

22,885,033 Total Patients Enrolled

US Endoscopy Group Inc.Industry Sponsor

2 Previous Clinical Trials

326 Total Patients Enrolled

Ray ShepherdPrincipal InvestigatorVirginia Commonwealth University

Frequently Asked Questions

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

How many individuals have the opportunity to participate in this trial?

"Affirmative. According to clinicaltrials.gov, this research study is actively recruiting applicants from one location, and 12 individuals are needed for the trial which was initially posted on October 30th 2023 before being updated most recently in October 12th of the same year."

Answered by AI

What potential risks are associated with Intervention for patients?

"Our internal assessment at Power gave this intervention a score of 1, as it is only in its first stage of trials and there is minimal data available on safety or efficacy."

Answered by AI

Is this research project admitting new participants?

"Affirmative. The clinicaltrials.gov website reports that this experiment is currently recruiting participants. It was originally posted on October 30th 2023 and last updated 12 days ago on the 10th of October 2023, with a requirement for 12 volunteers at 1 centre being necessary to move forward."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryospray Therapy for Benign Airway Stenosis

2023. "Cryospray Therapy for Benign Airway Stenosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06085209.