Intervention for Lung Disease

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Vanderbilt University Medical Center, Nashville, TNLung DiseaseSpray cryotherapy - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is a prospective, single center, interventional study evaluating the safety and efficacy of SCT in patients with BCAS.

Eligible Conditions
  • Lung Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

1 Primary · 6 Secondary · Reporting Duration: Measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

Month 6
Percent change in radiographic airway lumen volume at 6 months by CT
Month 6
Change in FEV1/FVC
Change in force vital capacity (FVC)
Change in forced expiratory volume in 1 second (FEV1)
Change in quality of life using the Clinical Chronic Obstructive Pulmonary Disease Questionnaire (COPD CCQ)
Change in six-minute walk distance (6MWD)
Month 6
Change in peak expiratory flow (PEF)

Trial Safety

Safety Progress

1 of 3

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Trial Design

2 Treatment Groups

Intervention
1 of 2
Control
1 of 2

Active Control

Non-Treatment Group

40 Total Participants · 2 Treatment Groups

Primary Treatment: Intervention · Has Placebo Group · N/A

InterventionActiveComparator Group · 3 Interventions: Spray cryotherapy, Ballon Dilation, Radial Incision · Intervention Types: Device, Device, Device
ControlPlaceboComparator Group · 2 Interventions: Ballon Dilation, Radial Incision · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: measurement intervals: 2 weeks pre-procedure, 2 weeks post procedure, 3 months and then 6 months post intervention.

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
783 Previous Clinical Trials
599,274 Total Patients Enrolled
Fabien Maldonado, MDPrincipal InvestigatorVanderbilt University Medical Center
4 Previous Clinical Trials
3,406 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You need to see a doctor who specializes in lung or throat procedures to treat a possible narrowing of your windpipe that is not cancerous.
Your airways are severely narrowed, making it difficult to breathe, as seen on a chest CT scan or you have symptoms suggesting breathing problems requiring medical evaluation.
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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