RheOx Bronchial Rheoplasty for Chronic Bronchitis

Norton Thoracic, Phoenix, AZ
Chronic BronchitisRheOx Bronchial Rheoplasty - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will assess the safety and effectiveness of a new treatment for chronic bronchitis called Bronchial Rheoplasty. A total of 270 patients will be randomized and followed for 2 years at up to 40 study centers.

Eligible Conditions
  • Chronic Bronchitis

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Matrix-based physical therapy
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Autologous matrix-induced chondrogenesis (AMIC)
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NOVOCART 3D

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: 6 and 12 months

1 month
Goblet Cell Hyperplasia
12 months
COPD Exacerbations
6 and 12 months
Cough Frequency
6 months
COPD Assessment Test (CAT) Score
Distal Airway Volume

Trial Safety

Phase-Based Safety

1 of 3

Similar Trials

1
Matrix-based physical therapy
1
Autologous matrix-induced chondrogenesis (AMIC)
3
NOVOCART 3D

Trial Design

2 Treatment Groups

RheOx Treatment
1 of 2
Sham Procedure
1 of 2

Experimental Treatment

Non-Treatment Group

270 Total Participants · 2 Treatment Groups

Primary Treatment: RheOx Bronchial Rheoplasty · Has Placebo Group · N/A

RheOx Treatment
Device
Experimental Group · 1 Intervention: RheOx Bronchial Rheoplasty · Intervention Types: Device
Sham Procedure
Device
ShamComparator Group · 1 Intervention: Sham Procedure · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 months

Who is running the clinical trial?

Gala Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
149 Total Patients Enrolled
4 Trials studying Chronic Bronchitis
149 Patients Enrolled for Chronic Bronchitis
Frank Sciurba, MDPrincipal InvestigatorUPMC; Division of Pulmonary and Critical Care Medicine
4 Previous Clinical Trials
2,517 Total Patients Enrolled
Arschang Valipour, MDPrincipal InvestigatorKarl-Landsteiner-Institute for Lung Research and Pulmonary Oncology; Vienna, Austria
3 Previous Clinical Trials
162 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a long-term cough that produces mucus for two years in a row and other possible causes have been ruled out.
You have a CAT score of 10 or higher.
You have a respiratory condition that affects your quality of life and your SGRQ score is 25 or higher.
You have significant symptoms related to chronic obstructive pulmonary disease (COPD) based on your responses to the first two questions of a survey called the CAT instrument.
You have smoked at least ten packs of cigarettes in your lifetime.

Who else is applying?

What state do they live in?
Oregon100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
Why did patients apply to this trial?
  • "I have severe copd & I want to make my quality of life better & prolong my life as long as possible!"
How many prior treatments have patients received?
0100.0%
References

Frequently Asked Questions

What is the total headcount of participants in this clinical trial?

"Yes, the clinicaltrials.gov page states that this medical trial is actively recruiting participants at present. This study was initially posted on April 7th 2021 and most recently updated on November 9th 2022; it seeks to enroll 270 individuals across 34 sites." - Anonymous Online Contributor

Unverified Answer

How many healthcare facilities are actively conducting this research project?

"University of Mississippi in Jackson, Lahey Hospital and Medical Center in Burlington, and Mayo Clinic in Rochester are some establishments hosting this trial. Altogether there are 34 other sites participating as well." - Anonymous Online Contributor

Unverified Answer

Are there any openings to participate in this trial at present?

"As indicated by the information on clinicaltrials.gov, this medical research endeavour is presently looking for participants. It was originally available to view on April 7th 2021 and underwent its last update in November 9th 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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