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Procedure

RheOx Device for Chronic Bronchitis (Gala_EFS Trial)

N/A
Waitlist Available
Research Sponsored by Gala Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is diagnosed with chronic bronchitis for a minimum of two years, where chronic bronchitis is defined clinically as chronic productive cough for three months in each of two successive years in a patient in whom other causes of productive cough have been excluded.
Subject has had 1 or more COPD exacerbations, defined as an acute worsening in respiratory symptoms that requires additional treatment, in the 12-months prior to enrollment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Gala_EFS Trial Summary

This trial is testing a new medical device to see if it is safe and helpful for people with chronic bronchitis.

Who is the study for?
This trial is for adults with chronic bronchitis for at least two years, an FEV1 between 30-80% of predicted, and a history of COPD exacerbations. They must have smoked the equivalent of ten pack-years and be able to undergo bronchoscopies. Exclusions include recent arrhythmias or lung cancer, severe other medical conditions, participation in another study within six weeks, inability to walk over 100 meters in six minutes, recent smoking or respiratory infections.Check my eligibility
What is being tested?
The RheOx system is being tested for its safety and effectiveness in treating patients with chronic bronchitis. The study involves participants undergoing bronchoscopy procedures where RheOx will be used to potentially improve their respiratory symptoms.See study design
What are the potential side effects?
While specific side effects are not listed here, typical risks may include those associated with bronchoscopy such as discomfort, bleeding, infection risk from the procedure itself; plus any potential reactions to medications used during the process like lidocaine.

Gala_EFS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have had chronic bronchitis for at least two years.
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I have had at least one severe COPD flare-up in the last year.
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My lung function test shows 30-80% of the expected result.
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I have smoked at least 10 pack-years.

Gala_EFS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety Through 12 Months: Rate of Serious Adverse Events
Secondary outcome measures
Clinical Utility: CAT Total Score at 12 Months
Clinical Utility: CAT Total Score at 6 Months
Clinical Utility: SGRQ Score at 12 Months
+1 more
Other outcome measures
Hospitalization Rate

Gala_EFS Trial Design

1Treatment groups
Experimental Treatment
Group I: RheOx TreatmentExperimental Treatment1 Intervention
RheOx Treatment (i.e., Bronchial Rheoplasty)

Find a Location

Who is running the clinical trial?

Gala Therapeutics, Inc.Lead Sponsor
4 Previous Clinical Trials
398 Total Patients Enrolled
4 Trials studying Chronic Bronchitis
398 Patients Enrolled for Chronic Bronchitis

Media Library

RheOx (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03631472 — N/A
Chronic Bronchitis Research Study Groups: RheOx Treatment
Chronic Bronchitis Clinical Trial 2023: RheOx Highlights & Side Effects. Trial Name: NCT03631472 — N/A
RheOx (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03631472 — N/A

Frequently Asked Questions

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

How many North American hospitals are currently conducting this research?

"This research project is operating out of Temple University School of Medicine in Philadelphia, Pennsylvania, University of Pittsburgh Medical Center in Pittsburgh, Iowa and the University of Iowa in Iowa City. Additionally, it has been extended to encompass 8 additional locations."

Answered by AI

Are there any opportunities to join this clinical experiment at present?

"The clinicaltrials.gov website conveys that this investigation is no longer recruiting participants after last being updated on April 11th 2022; however, 80 separate trials are still open to enrolment at present time. The trial was posted initially on July 6 2018."

Answered by AI

What would constitute a successful result from this trial?

"This clinical trial has been designed to measure the safety of a particular intervention over 12 months. Secondary objectives include tracking alterations in St. George's Respiratory Questionnaire (SGRQ) and COPD Assessment Test (CAT) scores at 6 and 12 month intervals, respectively."

Answered by AI
~3 spots leftby Mar 2025