Evaluating the Safety and Efficacy of dNerva Lung Denervation System in Patients With COPD

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Nuvaira, Inc.
Study ID
NCT07051707
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Targeted Lung Denervation (TLD) — DEVICE
    Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System.

Study Details

The dNerva Lung Denervation System is one-time treatment intended to improve breathing in Chronic Obstructive Pulmonary Disease (COPD) patients on standard medical care. The purpose of this study is to confirm the safety and efficacy of the Nuvaira Lung Denervation System in the treatment of COPD.

Key Dates

Start date
Feb 24, 2026
Status verified
Apr 2026
Primary completion
Apr 30, 2028
Completion
Oct 31, 2029

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Targeted Lung Denervation (TLD) treatment and continue on the same standard COPD medical care
    Targeted Lung Denervation (TLD)Therapy is a bronchoscopically guided minimally invasive one-time treatment using the dNerva Lung Denervation System. Patients will also continue taking their standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.
  • No Intervention: Continue on the same standard COPD medical care
    Continue taking their same standard of care COPD maintenance medication (at minimum LABA/ICS, LAMA/LABA or LABA/LAMA/ICS) that they were on prior to randomization.
  • Other: Targeted Lung Denervation (TLD) crossover treatment after 1-year follow-up for 'No Intervention' Arm
    Participants in 'No Intervention' arm who complete their 1-year follow-up will have the option to receive TLD treatment and will be followed for 1 year after the crossover treatment.

Primary Outcome Measure

The primary endpoint is improvement in FEV1 at 6 months. [ Time Frame: 6 months ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of Alabama-Birmingham Hospital - UAB Lung Health CenterBirminghamAlabama35233
Daniel Baugh
[email protected]
205-975-5295
Abbey West
[email protected]
205-934-0590
Surya Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
John Hazimouratides
[email protected]
904-953-8995
Maria Caruso
[email protected]
904-953-7897
Jose Soto Soto, MD (PRINCIPAL_INVESTIGATOR)
Henry Ford Hospital - Lung and Pulmonary CareDetroitMichigan48202
Saira Saif
[email protected]
313-916-2729
Deepti Naidu
[email protected]
313-916-2729
Daniel Kapadia, MD (PRINCIPAL_INVESTIGATOR)
Wake Forest School of MedicineSalemNorth Carolina27104
Anna Pippins
[email protected]
336-713-9184
Jessica Bon, MD (PRINCIPAL_INVESTIGATOR)
Ohio State University Medical Center - Ohio State Lung CenterColumbusOhio43210
Amy Miller
[email protected]
614-366-7935
Michael Woods
[email protected]
614-366-7935
Christian Ghattas, MD (PRINCIPAL_INVESTIGATOR)
Penn Highlands - Lung Innovations/Clinical Research AssociatesDuBoisPennsylvania15801
Rebecca Taylor
[email protected]
814-940-1212
Levi Miller
[email protected]
814-940-1212
Sandeep Bansai, MD (PRINCIPAL_INVESTIGATOR)
Temple University - Temple Lung CenterPhiladelphiaPennsylvania19140
Helga Criner
[email protected]
215-707-1359
Priya Walia
[email protected]
215-707-6812
Gerard Criner, MD (PRINCIPAL_INVESTIGATOR)
University of Pittsburgh Medical Center - UMPC Comprehensive Lung CenterPittsburghPennsylvania15213
Paula Consolaro
[email protected]
412-648-6404
Tiffany Ditter
[email protected]
412-648-6276
Frank Sciurba, MD (PRINCIPAL_INVESTIGATOR)
Virginia Commonwealth University Health SystemRichmondVirginia23298
Robin Toft
[email protected]
8046284570
Ray (Wes) Shepherd, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Isabel Gilbert
[email protected]
414-955-0578
Samantha Servi
[email protected]
414-955-7030
Johnathan Kurman, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Birmingham, AL

By condition
COPD
By specialty
PulmonologyLung disease
By research site
University of Alabama-Birmingham Hospital - UAB Lung Health Center· Birmingham, ALMayo Clinic Jacksonville· Jacksonville, FLHenry Ford Hospital - Lung and Pulmonary Care· Detroit, MIWake Forest School of Medicine· Salem, NCOhio State University Medical Center - Ohio State Lung Center· Columbus, OHPenn Highlands - Lung Innovations/Clinical Research Associates· DuBois, PA

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