Ryme Medical TLD Pilot Study

Ryme Medical

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Device: Targeted Lung Denervation

Study type: Interventional

Funder types: Industry

Identifiers

NCT05967091

2023-01

Details and patient eligibility

About

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

Full 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)

Enrollment: 60 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

Targeted Lung Denervation

Experimental group

Description:

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

Treatment:

Device: Targeted Lung Denervation