Primary ObjectiveThe primary objective of the study is to evaluate the safety of The Ryme Medical Lung Denervation System.Secondary ObjectivesThe secondary objective of the study is to evaluate the performance of The Ryme Medical Lung Denervation…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary safety analysis will be the assessment of incidence and
characterization of any serious adverse events associated with the Ryme Lung
Denervation System through 30 days.
Secondary outcome
The analysis of device performance will be the assessment of:
• Device Success:
Successful delivery and retrieval of the catheter
• Technical Success:
Device success with the ability to deliver cryoablation to each intended
location
Device performance will be assessed at the completion of the Index Procedure.
Background summary
This research is an Early Feasibility Study of a non-surgical procedure called
targeted lung denervation (TLD) using a new, experimental device.
The experimental device is called the Ryme Medical Lung Denervation System,
manufactured by a company called Ryme Medical, Inc. in Mountain View,
California, USA. This research is being conducted by and is sponsored by Ryme
Medical.
With COPD there are nerves within the lungs that potentially overreact to
irritation (e.g., allergens such as pollution, infections). When the nerves
overreact, they can cause the airways to narrow and cause the lungs to create
more than normal amounts of mucus making it more difficult to breathe and
causing COPD flare-ups.
The TLD procedure with the Ryme Medical Lung Denervation System is designed to
reduce this airway nerve activity, which may potentially reduce how often a
patient with COPD has COPD flare-ups or reduce how severe the symptoms become.
The TLD procedure uses cryoablation (freezing temperatures) to *inactivate*
specific nerve branches in the airway that are believed to contribute to COPD
flare-ups.
The Ryme Medical Lung Denervation System has undergone extensive bench-top
testing and has been successfully used in pigs and sheep, which have similar
lung structures to humans.
Study objective
Primary Objective
The primary objective of the study is to evaluate the safety of The Ryme
Medical Lung Denervation System.
Secondary Objectives
The secondary objective of the study is to evaluate the performance of The Ryme
Medical Lung Denervation System.
Study design
The study is a prospective, multi-center, non-randomized, single-arm study to
evaluate the safety and performance of The Ryme Medical Lung Denervation System
in patients with chronic obstructive pulmonary disease (COPD).
Intervention
TLD procedure with the Ryme Medical Lung Denervation System
Study burden and risks
Potential Risks of the Study Procedure and Investigational Device
The risks associated with bronchoscopy and general anesthesia are the
predominant risks of the study. The majority of the risks of the
investigational TLD procedure are similar to the risks of bronchoscopy as noted
in Table 6-1. The likelihood of these risks is unknown, but the frequency is
expected to be similar to bronchoscopy.
Potential risks associated the study device and the TLD procedure may include
but are not limited to those outlined in Table 6-2. The likelihood of these
risks is anticipated to be rare, but the actual rates are unknown, as this is
the initial introduction of the investigational Ryme Medical Lung Denervation
System into a human population. However, bench-top testing and animal studies
have demonstrated that the TLD procedure can be performed safely and reliably.
The Ryme Medical Lung Denervation System performed as intended in both the
porcine and ovine models. Bench testing and animal studies of the system have
demonstrated adequate safety at extended chronic timepoints and performance to
provide justification and confidence to transition to the next phase of
clinical testing via human clinical studies. Refer to the Investigator Brochure
for additional information.
There may be other unknown complications that may occur as a result of this
procedure. If these or any of the above complications occur, they may lead to
repeat or prolonged hospitalization, repeat procedures, emergency surgery,
other emergency procedures, or in rare cases, death. The study doctor and/or
his research staff will make every effort to minimize additional risks.
Potential Benefits
Patients who are eligible for this study suffer from moderate or severe COPD
and are highly symptomatic. A participant may benefit from the TLD procedure.
The potential benefits include a reduction of COPD symptoms such as reduced
cough, reduced sputum production, reduced breathlessness and/or reduced or less
frequent exacerbations. Patients may also experience other possible health
improvements and/or symptom relief associated with that reduced symptom burden
of COPD such as improvement in quality of life and/or functional improvement
such as increased exercise endurance.
Other benefits of participation in this study are altruistic and are related to
the knowledge and information that will be obtained to further the design and
development of The Ryme Medical Lung Denervation System and treatment of COPD.
Risk Management
All efforts will be made to minimize the identified risks by taking the
following measures:
• Investigational sites will be confirmed to have adequate resources, staff and
facilities to perform the procedures as outlined in the schedule of assessments
• Investigators will be physicians who have training and experience in
performing bronchoscopic procedures. Investigators will be trained in proper
procedure performance and device operations prior to patient treatment
• Defined study protocol, including specific inclusion/exclusion criteria to
enroll appropriate patients in the study
• Ongoing monitoring of study data and results
Risk-Benefit Rationale
This pilot study will enroll patients with moderate or severe COPD with
significant symptom burden with limited relief from available treatment options.
These high-risk patients have limited treatment options and are at high risk of
morbidity and mortality. The non-surgical, minimally invasive, TLD procedure
may provide symptom relief or mediate disease progresses providing an adjunct
therapy for patients suffering from COPD.
Hospital Drive, Suite 300 2495
Mountain view 94040
US
Hospital Drive, Suite 300 2495
Mountain view 94040
US
Listed location countries
Age
Inclusion criteria
1. Patient has diagnosis of chronic obstructive pulmonary disease with
post-bronchodilator FEV1/FVC of < 70% of predicted and FEV1 >=30% and < 80%
2. Patient has symptomatic COPD, despite treatment with established best
guideline directed medical therapy, demonstrated by an mMRC grade >= 2 or CAT
score >= 10
3. Patient is >=40 years of age at the time of enrollment
4. Patient has a smoking history of at least 10 pack years, and/or has
significant environmental exposure equivalent in the opinion of the investigator
5. Patient has provided written informed consent
6. Patient is willing and able to comply with the study protocol
7. Patient is a candidate for bronchoscopy in the opinion of the Investigator
Exclusion criteria
1. Patient has anatomy precluding proper device delivery or function and/or
high likelihood of incomplete treatment
2. Patient has had recent COPD exacerbation, or respiratory infection, within 6
weeks of screening or is currently taking antibiotics and/or steroids for
treatment of an exacerbation
3. Patient has undergone prior lung intervention with device currently
implanted, and/or had administration of therapeutic cryo or radio frequency
(RF) in the airway
4. Patient has asthma as defined by the current Global Initiative for Asthma
(GINA) guidelines
5. Patient has history of mycobacterium avium complex (MAC) lung infection
requiring treatment
6. Patient has other non-COPD lung disease or condition affecting the lungs
such as bronchiectasis, allergic bronchopulmonary aspergillosis, interstitial
lung disease, or active tuberculosis (or currently receiving treatment for
tuberculosis)
7. Patient has pulmonary nodule or cavity that in the opinion of the
Investigator may require intervention during the course of study participation
8. Patient has malignancy requiring treatment, is actively receiving
chemotherapy or radiation therapy and/or has received treatment within 6 months
of screening
9. Patient is using any tobacco products, using e-cigarettes, vaping or using
other inhaled non-pharmacological substance
10. Patient has documented history of myocardial infarction, cerebrovascular
accident, or transient ischemic attack within 6 months of screening
11. Patient has left ventricular ejection fraction <= 45%
12. Patient has clinically significant serious or unstable medical conditions
(e.g., uncontrolled diabetes or hypertension)
13. Patient has known contraindication or allergy (that cannot be medical
controlled) to any of the following: medications required for bronchoscopy;
general anesthesia; or materials comprising the patient contacting portion of
the device
14. Patient is unable or unwilling to discontinue antiplatelet or anticoagulant
therapy for the index procedure
15. Patient has any other condition, in the opinion of the Investigator, that
may interfere with study follow-up or completion
16. Patient is currently enrolled in another clinical study that has not
completed follow-up
17. Patient is pregnant, nursing, or intent to become pregnant during study
participation
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT05967091 |
| CCMO | NL85849.042.24 |