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Gala Early Feasibility Study of RheOx (Gala_EFS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03631472
Recruitment Status : Active, not recruiting
First Posted : August 15, 2018
Last Update Posted : November 26, 2019
Sponsor:
Information provided by (Responsible Party):
Gala Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Chronic Bronchitis Copd Bronchitis Device: RheOx Not Applicable

Detailed Description:

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

Two sessions of treatment will be delivered one month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session (approximately one month after the right side is treated). Treatment will be delivered by a respiratory physician (interventional pulmonologist) in a tertiary teaching hospital during a bronchoscopic procedure. The bronchoscopy will be delivered during general anesthesia. It is anticipated that the bronchoscopic procedure will last less than 60 minutes in total. Treatment will be deemed to have been delivered following the successful treatment during the two bronchoscopies.

Subjects will be required to submit tests during the study including three CT scans (lung), respiratory function tests, exercise testing.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Treatment with RheOx
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility Study: A Safety Evaluation of RheOx on Patients With Chronic Bronchitis in the United States
Actual Study Start Date : July 6, 2018
Estimated Primary Completion Date : August 30, 2020
Estimated Study Completion Date : August 30, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RheOx Treatment
RheOx Treatment (i.e., Bronchial Rheoplasty)
Device: RheOx
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.
Other Names:
  • Bronchial Rheoplasty
  • Gala Airway Treatment System




Primary Outcome Measures :
  1. Safety at 12 months: Incidence of serious adverse events [ Time Frame: 12 months ]
    Incidence of serious adverse events associated with RheOX through 6 months.


Secondary Outcome Measures :
  1. Clinical Utility - SGRQ at 6 months [ Time Frame: 6 months ]
    The change from baseline at 6 months in St. George's Respiratory Questionnaire (SGRQ)

  2. Clinical Utility - SGRQ as 12 months [ Time Frame: 12 months ]
    The change from baseline at 12 months in St. George's Respiratory Questionnaire (SGRQ)

  3. Clinical Utility - CAT at 6 months [ Time Frame: 6 months ]
    The change from baseline at 6 months in COPD Assessment Test (CAT)

  4. Clinical Utility - CAT at 12 months [ Time Frame: 12 months ]
    The change from baseline at 12 months in COPD Assessment Test (CAT)


Other Outcome Measures:
  1. Clinical Utility - Hospitalization Rates [ Time Frame: 12 months ]
    The rate of hospitalizations



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Subject has a SGRQ score of greater than or equal to 25 and CAT score of greater than or equal to 10.
  6. Subject has a cigarette smoking history of at least ten packs years.
  7. Subject in the opinion of the site investigator is able to adhere to and undergo two bronchoscopies and has provided a signed informed consent.

Exclusion Criteria:

  1. 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.
  2. Subject is taking > 10 mg of prednisolone or prednisone per day.
  3. Subject has an implantable cardioverter defibrillator or pacemaker.
  4. Subject has a history of cardiac arrhythmia within past two years.
  5. Subject has history of unresolved lung cancer in last 5 years.
  6. Subject has bullous disease as defined by bullae exceeding 3 cm in diameter on HRCT.
  7. Subject has pulmonary nodule or cavity rthat in the judgement of the investigator may require intervention during the course of the study.
  8. 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.
  9. Subject has clinically significant cardiomyopathy.
  10. 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.
  11. Subject actively smoked (including tobacco, marijuana, e-cigarettes, vaping, etc.) within the last 6 months.
  12. Subject has the inability to walk over 100 meters in 6 minutes.
  13. 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.
  14. Subject has uncontrolled GERD.
  15. Subject has sever pulmonary hypertension.
  16. Subject has known sensitivity to medication required to perform bronchoscopy (such as lidocaine, atropine, and benzodiazepines).
  17. Subject is pregnant, nursing, or planning to get pregnant during study duration.
  18. Subject has received chemotherapy within the past 6 months or is expected to receive chemotherapy during participation in this study.
  19. Subject is or has been in another clinical investigational study within 6 weeks of baseline.
  20. Subject on anticoagulation for cardiovascular indications and is unable to have anticoagulants (i.e., Aspirin, Plavix, Coumadin) withheld for at least seven days prior to bronchoscopy in the opinion of the Investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631472


Locations
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United States, Alabama
University of Alabama Lung Health Center
Birmingham, Alabama, United States, 35249
United States, Florida
Mayo Clinic Florida
Jacksonville, Florida, United States, 32224
United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Maryland
MedStar Health
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Beth Israel Deaconess
Boston, Massachusetts, United States, 02215
United States, Pennsylvania
Temple University School of Medicine
Philadelphia, Pennsylvania, United States, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
Gala Therapeutics, Inc.
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Responsible Party: Gala Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT03631472    
Other Study ID Numbers: CS003
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
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Bronchitis
Bronchitis, Chronic
Acute Disease
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive