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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05967091




Registration number
NCT05967091
Ethics application status
Date submitted
14/07/2023
Date registered
1/08/2023
Date last updated
13/08/2025

Titles & IDs
Public title
Ryme Medical TLD Pilot Study
Scientific 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
Secondary ID [1] 0 0
2023-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Targeted Lung Denervation

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


Treatment: Devices: Targeted Lung Denervation
Targeted Lung Denervation (TLD) is a bronchoscopically guided, minimally invasive procedure using the Ryme Medical Lung Denervation System
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Device Safety
Timepoint [1] 0 0
30 Days
Secondary outcome [1] 0 0
Device Success
Timepoint [1] 0 0
Day 0
Secondary outcome [2] 0 0
Technical Success
Timepoint [2] 0 0
Day 0

Eligibility
Key inclusion criteria
Key

* 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
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
6/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Health - The Royal Melbourne Hospital - Melbourne
Recruitment hospital [2] 0 0
Macquarie University - Sydney
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment postcode(s) [2] 0 0
- Sydney
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
Denmark
State/province [2] 0 0
Copenhagen
Country [3] 0 0
Georgia
State/province [3] 0 0
Tbilisi
Country [4] 0 0
Netherlands
State/province [4] 0 0
Groningen
Country [5] 0 0
United Kingdom
State/province [5] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ryme Medical, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT05967091