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Clinical Trials/NCT05967091
NCT05967091Active, not recruitingNot Applicable

Targeted Lung Denervation (TLD) With the Ryme Medical Lung Denervation System in Patients With Chronic Obstructive Pulmonary Disease (COPD) - Ryme Medical TLD Pilot Study

Ryme Medical, Inc.7 sites in 6 countries60 target enrollmentStarted: March 6, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Sponsor
Enrollment
60
Locations
7
Primary Endpoint
Device Safety
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD) - Ryme Medical TLD Pilot Study

Detailed Description

The study is a prospective, multi-center, non-randomized study to evaluate the safety and performance of the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Symptomatic chronic obstructive pulmonary disease
  • •≥40 years of age
  • •Smoking history of at least 10 pack years
  • •Candidate for bronchoscopy in the opinion of the Investigator

Exclusion Criteria

  • •Recent COPD exacerbation or respiratory infection
  • •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

Arms & Interventions

Targeted Lung Denervation

Experimental

Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System

Intervention: Targeted Lung Denervation (Device)

Outcomes

Primary Outcomes

Device Safety

Time Frame: 30 Days

Serious adverse events associated with the Ryme Medical Lung Denervation System

Secondary Outcomes

  • Device Success(Day 0)
  • Technical Success(Day 0)

Investigators

Sponsor
Ryme Medical, Inc.
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (7)

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