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RheOx Registry Study in Europe

Primary Purpose

Chronic Bronchitis, COPD

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

RheOx

About this trial

This is an interventional treatment trial for Chronic Bronchitis

Eligibility Criteria

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Inclusion Criteria:

Patient has moderate to severe Chronic Bronchitis

Exclusion Criteria:

Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device.
Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block.
Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.

Sites / Locations

Otto Wagner SpitalRecruiting
Pneumologie Thoraxklinik Heidelberg gGmbH University of HeidelbergRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

RheOx Treatment

Arm Description

RheOx is a CE-marked 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.

Outcomes

Primary Outcome Measures

Safety: Incidence of SAEs

Incidence of serious adverse events associated with RheOx treatment through 24 months

Quality of Life: CAT

COPD Assessment Test (CAT) questionnaire

Quality of Life: SGRQ

St. George Respiratory Questionnaire

Secondary Outcome Measures

Pulmonary Function: FEV1

Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.

Pulmonary Function: FVC

Forced Vital Capacity

COPD Exacerbations

Full Information

NCT ID

NCT04182841

First Posted

November 27, 2019

Last Updated

March 21, 2022

Sponsor

Gala Therapeutics, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04182841

Brief Title

RheOx Registry Study in Europe

Official Title

RheOx European Post-Market Clinical Study

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 9, 2020 (Actual)

Primary Completion Date

December 15, 2024 (Anticipated)

Study Completion Date

December 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gala Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

Post-market clinical study (registry study) to collect post-market safety and clinical utility data in European patients with chronic bronchitis treated with RheOx.

Detailed Description

RheOx is a device-based, energy delivery system that delivers high frequency short duration energy to 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 anaesthesia. 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 to several tests and questionnaires during the study including respiratory function tests.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Bronchitis, COPD

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

RheOx Treatment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

RheOx Treatment

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

RheOx

Intervention Description

RheOX is a CE-marked 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.

Primary Outcome Measure Information:

Title

Safety: Incidence of SAEs

Description

Incidence of serious adverse events associated with RheOx treatment through 24 months

Time Frame

Through end of study (24 months post bilateral treatment)

Title

Quality of Life: CAT

Description

COPD Assessment Test (CAT) questionnaire

Time Frame

Through end of study (24 months post bilateral treatment)

Title

Quality of Life: SGRQ

Description

St. George Respiratory Questionnaire

Time Frame

Through end of study (24 months post-bilateral treatment)

Secondary Outcome Measure Information:

Title

Pulmonary Function: FEV1

Description

Forced expiratory volume (FEV). FEV1 is the amount of air you can force from your lungs in one second.

Time Frame

Through end of study (24 months post-bilateral treatment)

Title

Pulmonary Function: FVC

Description

Forced Vital Capacity

Time Frame

Through end of study (24 months post-bilateral treatment)

Title

COPD Exacerbations

Description

COPD Exacerbations

Time Frame

Through end of study (24 months post-bilateral treatment)

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patient has moderate to severe Chronic Bronchitis Exclusion Criteria: Patient has an implantable cardioverter defibrillator, pacemaker, or any other implantable electronic device. Patient has history of ventricular tachyarrhythmia or any clinically significant atrial tachyarrhythmia (i.e., abnormality with vital signs) and/or history of type II second or third degree AV block. Patient has airway stent(s), valves, coils, or other lung implant/prosthesis.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Jeff Keeney

Phone

650-268-4252

jeff@galatherapeutics.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

William Krimsky, MD

Organizational Affiliation

Gala Therapeutics, Inc.

Official's Role

Study Director

Facility Information:

Facility Name

Otto Wagner Spital

City

Wien

ZIP/Postal Code

A-1140

Country

Austria

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kelly Gross

Phone

0043 664 4385355

blvr.koordinator@gmail.com

First Name & Middle Initial & Last Name & Degree

Arschang Valipour, MD

Facility Name

Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg

City

Heidelberg

State/Province

Baden-Württemberg

ZIP/Postal Code

69047

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Brigitte Rump

Phone

49 (6221) 396-1211

brigitte.rump@med.uni-heidelberg.de

First Name & Middle Initial & Last Name & Degree

Felix Herth, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

RheOx Registry Study in Europe

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