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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ACTIVE_NOT_RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-06
2026-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Targeted Lung Denervation
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System
Targeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
Interventions
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Targeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* ≥40 years of age
* Smoking history of at least 10 pack years
* Candidate for bronchoscopy in the opinion of the Investigator
Exclusion Criteria
* Prior lung intervention with device in place
* Pulmonary nodule or malignancy requiring treatment
* Current chemotherapy or radiation therapy and/or has received treatment within 6 months
* Current smoker, using e-cigarettes or vaping, or taking any inhaled substances not prescribed by a physician
* Clinically significant serious or unstable medical conditions (e.g., heart disease requiring treatment, uncontrolled diabetes)
* Pregnant, nursing, or intent to become pregnant during study duration
40 Years
ALL
No
Sponsors
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Ryme Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Melbourne Health - The Royal Melbourne Hospital
Melbourne, , Australia
Macquarie University
Sydney, , Australia
Karl Landsteiner Institute for Lung Research
Vienna, , Austria
Rigshospitalet
Copenhagen, , Denmark
Healthycore
Tbilisi, , Georgia
University of Groningen Medical Center
Groningen, , Netherlands
Royal Brompton
London, , United Kingdom
Countries
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Other Identifiers
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2023-01
Identifier Type: -
Identifier Source: org_study_id
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