Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

COPD Clinical Trial

— DISCOVER TLD  

Official title:

Discovery of the Impact of Targeted Lung Denervation (TLD) on the Severe and Very Severe COPD Population

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03213080
• Other study ID #: D0476
• Status: Withdrawn
• Start date: December 2017
• Est. completion date: September 2021

Study information

• Verified date: February 2019
• Source: Nuvaira, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The DISCOVER TLD study is a multicenter, prospective, single-arm study designed to record the clinical outcomes of the CE-marked Nuvaira™ Lung Denervation System, in a subset of its CE-marked approved indication. This study is being conducted in Europe.

Description:

The purpose of this study is to evaluate the overall COPD patient experience with the Nuvaira™ Lung Denervation System and allow for the continued collection of safety and effectiveness data on the CE-marked product. The study is a multicenter, prospective, single-arm study designed to include patients, on average, who fall within a more severe stage of COPD, defined as 20-45% FEV1 percent predicted. Subjects will remain on respiratory medications per their standard of care and will be followed and tested per standard of care throughout the study.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2021
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diagnosis of COPD with 20% = FEV1 = 45% and FEV1/FVC < 70% (post-bronchodilator)

• History of long-term smoking, but non-smoking for a minimum of 2 months prior to study consent

• Patient is a candidate for bronchoscopy

• Patient agrees to all follow-up and provides written informed consent.

Exclusion Criteria:

• Presence of lung or chest implants (eg. metal stent, valves, coils)

• Pregnancy

• Pre-existing pulmonary hypertension

• Patient has a pacemaker, internal defibrillator, or other implantable electronic device

• Inappropriate bronchial anatomy for procedure (per CT scan)

• Previous abdominal surgical procedures on stomach, esophagus or pancreas

• Previous treatment with TLD Therapy (in same areas)

• Known allergy to bronchoscopy or general anesthesia medications

• Inability to tolerate single lung ventilation for at least 2 min, 30 sec

• Patient has a GCSI score of = 18 at time of screening visit

Related Conditions & MeSH terms

• COPD

Intervention

Device:
• Targeted Lung Denervation (TLD)
Targeted Lung Denervation (TLD) procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nuvaira, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Quality of Life (QOL)	Changes in the St. George's Respiratory Questionnaire for COPD patients (SGRQ-C) over time will be assessed. Comparisons will be made to baseline score.	6 months; 12 months; 24 months post-procedure
Secondary	Changes in Pulmonary Function	Basic spirometry tests including FEV1, FVC, forced impulse oscillometry, nitrogen wash-out measures will be performed per standard of care over time. Comparisons will be made to baseline measures.	6 months, 12 months, 24 months post-procedure
Secondary	Change in 6-Minute Walk Test	Change in 6MWT over time	6 months, 1 year, 2 years
Secondary	Respiratory-related Adverse Events	Respiratory-related adverse events will be collected throughout the registry. Rates of respiratory-related adverse events will be reported and compared to historical data.	24 months
Secondary	Freedom from Device-related Adverse Events	Device-related adverse events will be collected through 6 months post-procedure. The number of subjects free from a device-related adverse event will be reported.	Peri-procedure (within 7 days); 1 month and 6 months

External Links

•   Nuvaira Website with description of TLD procedure