Ryme Medical TLD Pilot Study
Research type
Research Study
Full title
Targeted lung denervation (TLD) with the Ryme Medical Lung Denervation System in patients with chronic obstructive pulmonary disease (COPD)
IRAS ID
337994
Contact name
Pallav Shah
Contact email
Sponsor organisation
Ryme Medical
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 31 days
Research summary
Chronic Obstructive Pulmonary Disease (COPD) is a progressive lung disease that is a combination of damage to lung tissues that leads to narrowing of the airways. Medications are generally used to help manage symptoms and prevent COPD exacerbations. Within the lungs in patients with COPD, the nerves may contribute to airway narrowing and mucus production making it more difficult to breathe and cause exacerbations. Targeted lung denervation (TLD) is a non-surgical procedure designed to target these overactive nerves.
The Ryme Medical Lung Denervation System is a new, experimental device that consists of a balloon catheter (a small flexible tube with a balloon at the end) and a machine (console), which allows the doctor to control and monitor balloon inflation and to apply the treatment. Following the placement of the catheter in the airways, the console delivers cold gas (nitrous oxide) to the balloon, to freeze the nerves.
The balloon will be held in place for a few minutes to treat the nerves and then will be allowed to thaw and be deflated before moving to the next area. The doctor will determine how many locations within the airway to freeze; if both lungs will be treated and/or if more than one procedure is needed to complete the treatment.
The console has not been approved for treatment for COPD and this is the first study in man. Although the benefits and risks of the device of the treatment in COPD are relatively unknown, the Ryme Medical Lung Denervation System has undergone extensive bench-top testing and has been used in animal models, which have similar lung structures to humans.
The study will include up to 40 patients in 4 sites in Europe and the UK, with patient enrolment occurring over an approx. 12month period and a 12-month post procedure follow up for patients.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
24/SC/0123
Date of REC Opinion
16 May 2024
REC opinion
Further Information Favourable Opinion