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NCT05967091 Clinical Trial

Ryme Medical TLD Pilot Study

Chronic Obstructive Pulmonary Disease Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05967091
Other study ID # 2023-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 2023
Est. completion date December 2025

Study information
Verified date July 2023
Source Ryme Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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)

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Key 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 Key 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Targeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Ryme Medical, Inc.

Outcome
Type Measure Description Time frame Safety issue
Primary Device Safety Serious adverse events associated with the Ryme Medical Lung Denervation System 30 Days
Secondary Device Success Day 0
Secondary Technical Success Day 0
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