Ryme Medical TLD Pilot Study

Sponsor

Ryme Medical, Inc. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05967091

Collaborator

(none)

Enrollment

Arm

Anticipated Duration (Months)

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Targeted Lung Denervation	N/A

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

Anticipated Enrollment :

60 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Single-arm, non-randomizedSingle-arm, non-randomized

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Targeted Lung Denervation Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System	Device: Targeted Lung Denervation Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System Other Names: TLD

Arm

Intervention/Treatment

Experimental: Targeted Lung Denervation

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

Device: Targeted Lung Denervation

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

Other Names:

TLD

Outcome Measures

Primary Outcome Measures

Device Safety [30 Days]
Serious adverse events associated with the Ryme Medical Lung Denervation System

Secondary Outcome Measures

Device Success [Day 0]
Technical Success [Day 0]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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