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Ryme Medical TLD Pilot Study

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Targeted Lung Denervation
Sponsored by
Ryme Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Targeted Lung Denervation

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Device Safety
    Serious adverse events associated with the Ryme Medical Lung Denervation System

    Secondary Outcome Measures

    Device Success
    Technical Success

    Full Information

    First Posted
    July 14, 2023
    Last Updated
    July 21, 2023
    Sponsor
    Ryme Medical, Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05967091
    Brief Title
    Ryme Medical TLD Pilot Study
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ryme Medical, Inc.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. 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
    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)

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Obstructive Pulmonary Disease
    Keywords
    COPD, Dyspnea, Lung denervation, Bronchoscopic intervention, Lung disease, Lung diseases, obstructive, Respiratory tract diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single-arm, non-randomized
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Targeted Lung Denervation
    Arm Type
    Experimental
    Arm Description
    Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System
    Intervention Type
    Device
    Intervention Name(s)
    Targeted Lung Denervation
    Other Intervention Name(s)
    TLD
    Intervention Description
    Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
    Primary Outcome Measure Information:
    Title
    Device Safety
    Description
    Serious adverse events associated with the Ryme Medical Lung Denervation System
    Time Frame
    30 Days
    Secondary Outcome Measure Information:
    Title
    Device Success
    Time Frame
    Day 0
    Title
    Technical Success
    Time Frame
    Day 0

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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