Gala Early Feasibility Study of RheOx

NCT03631472 | Unknown Results FDA Device

• 1 other identifier: CS003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 8

Brief Summary

An early feasibility study (EFS) to assess the safety and clinical utility of RheOx on patients with chronic bronchitis in the United States.

Conditions

Chronic Bronchitis; Copd Bronchitis

Outcome Measures

Primary Outcomes (1)

• Safety Through 12 Months: Rate of Serious Adverse Events

  Rate of serious adverse events of interest through 12 months. Events of interest are death, COPD exacerbation requiring hospitalization, pneumothrax within 2 days of procedure, pneumonia within 7 days of procedure, respiratory failure or arrhythmia requiring intervention.

  12 months

Secondary Outcomes (4)

• Clinical Utility: SGRQ Score at 6 Months

  6 months

• Clinical Utility: SGRQ Score at 12 Months

  12 months

• Clinical Utility: CAT Total Score at 6 Months

  6 months

• Clinical Utility: CAT Total Score at 12 Months

  12 months

Other Outcomes (1)

• Hospitalization Rate

  12 months

Study Arms (1)

RheOx Treatment

EXPERIMENTAL

RheOx Treatment (i.e., Bronchial Rheoplasty)

Device: RheOx

Interventions

RheOx DEVICE

RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.

Also known as: Bronchial Rheoplasty, Gala Airway Treatment System

RheOx Treatment

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 responds to the first two questions of the CAT must sum to at least 7 points. If the sum of the first two CAT questions is 6 points and the subject's total CAT score is greater than 20 points, the subject may be enrolled.
• Subject has preprocedure post-bronchodilator FEV1 of greater than or equal to 30% and less than or equal to 80% of predicted within three months of enrollment.
• 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.
• Subject has a SGRQ score of greater than or equal to 25 and CAT score of greater than or equal to 10.
• Subject has a cigarette smoking history of at least ten packs years.
• Subject in the opinion of the site investigator is able to adhere to and undergo two bronchoscopies and has provided a signed informed consent.

You may not qualify if:

• Subject has lower respiratory infection (e.g., common cold, pneumonia, MAI, tuberculosis) within the six weeks prior to the initial treatment bronchoscopy or mild or moderate COPD exacerbation (per GOLD guidelines) within 4 weeks of the procedure.
• Subject is taking \> 10 mg of prednisolone or prednisone per day.
• Subject has an implantable cardioverter defibrillator or pacemaker.
• Subject has a history of cardiac arrhythmia within past two years.
• Subject has history of unresolved lung cancer in last 5 years.
• Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT.
• Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may require intervention during the course of the study.
• Subject has prior lung surgery, such as lung transplant, LVRS, lung implant/prosthesis, metal stent, valves, coils, bullectomy, segmentectomy, or lobectomy. Pneumothorax without lung resection is acceptable. Pleural procedures without surgery are acceptable.
• Subject has clinically significant cardiomyopathy.
• Subject has severe bronchiectasis as outlined in the report of the CT scan of the chest by the interpreting radiologist or in the view of the PI, those findings bronchiectasis or any other significant second lung disease, are the main drivers of the patient's clinical symptoms.
• Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
• Subject has the inability to walk over 100 meters in 6 minutes.
• Subject has clinically significant serious medical conditions, such as: congestive heart failure, angina or myocardial infarction in the past year, renal failure, liver disease cerebrovascular accident within the past 6 months, uncontrolled diabetes, uncontrolled hypertension or autoimmune disease.
• Subject has uncontrolled GERD.
• Subject has sever pulmonary hypertension.

Sponsors & Collaborators

• Gala Therapeutics, Inc.: lead

Study Sites (8)

University of Alabama Lung Health Center

Birmingham, Alabama, 35249, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MedStar Health

Baltimore, Maryland, 21237, United States

Location

Beth Israel Deaconess

Boston, Massachusetts, 02215, United States

Location

Temple University School of Medicine

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

• Krimsky WS, Mammarappallil JG, Kim V, Bannan B, Charbonnier JP, Hatton BA, Sciurba FC. Airway Mucus Plugging in Chronic Bronchitis and the Impact of Bronchial Rheoplasty. Chest. 2026 Jan;169(1):73-83. doi: 10.1016/j.chest.2025.06.022. Epub 2025 Jun 24.

  PMID: 40571054 DERIVED

• Sciurba FC, Dransfield MT, Kim V, Marchetti N, Comellas A, Hogarth DK, Majid A. Bronchial rheoplasty for chronic bronchitis: 2-year results from a US feasibility study with RheOx. BMJ Open Respir Res. 2023 Dec 26;10(1):e001710. doi: 10.1136/bmjresp-2023-001710.

  PMID: 38151258 DERIVED

MeSH Terms

Conditions

Bronchitis, Chronic

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: James Stambaugh SVP of Clinical Affairs
• Organization: Gala Therapeutics

jstambaugh@galatherapeutics.com

4087186834

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Treatment with RheOx

Study Record Dates

• First Submitted: August 13, 2018
• First Posted: August 15, 2018
• Study Start: July 6, 2018
• Primary Completion: January 30, 2021
• Study Completion: December 30, 2024
• Last Updated: May 9, 2022
• Results First Posted: May 9, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)