Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2020-01-09
2025-12-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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RheOx Treatment
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.
RheOx
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.
Interventions
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RheOx
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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
ALL
No
Sponsors
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Gala Therapeutics, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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William Krimsky, MD
Role: STUDY_DIRECTOR
Gala Therapeutics, Inc.
Locations
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Otto Wagner Spital
Vienna, , Austria
Pneumologie Thoraxklinik Heidelberg gGmbH University of Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CS005
Identifier Type: -
Identifier Source: org_study_id
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