Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (IPS-I)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Holaira Identifier:
First received: November 29, 2011
Last updated: February 17, 2016
Last verified: February 2016
The purpose of this study is to evaluate the safety of Targeted Lung Denervation Therapy (or TLD TherapyTM) in patients suffering from COPD. Technical feasibility of the IPS SystemTM will also be evaluated through confirmation of successful application of TLD Therapy.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD)
Device: TLD Therapy (IPS SystemTM)
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation (TLD) Therapy in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) - A Safety Study

Resource links provided by NLM:

Further study details as provided by Holaira:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 365 days post procedure ] [ Designated as safety issue: Yes ]
    Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.

Secondary Outcome Measures:
  • Technical Feasibility [ Time Frame: At time of Treatment ] [ Designated as safety issue: No ]
    The ability to access the target treatment area and deliver RF energy to the target treatment site.

Enrollment: 22
Study Start Date: October 2011
Estimated Study Completion Date: March 2016
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Targeted Lung Denervation
Targeted Lung Denervation
Device: TLD Therapy (IPS SystemTM)
Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.
Other Name: TLD Therapy, Targeted Lung Denervation Therapy


Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • FEV1 30% to 60%
  • FEV1/FVC <70%
  • Prior smoker (at least 10 pack years)
  • Quit smoking for at least 6 months

Exclusion Criteria:

  • Pulmonary hypertension, peripheral edema suggesting CHF or polycythemia
  • Prior lung transplant, LVR, LVRS, median sternotomy, bullectomy or lobectomy
  • Pulmonary nodule requiring surgery
  • Presence of implantable electronic devices
  • Active respiratory infection within recent weeks
  • COPD exacerbation within recent weeks
  • Recent Myocardial infarction (MI)
  • Recent and unstable or life threatening arrhythmia
  • Malignancy treated with radiation or chemotherapy within the last 2 years
  • Presence or clinical diagnosis of other respiratory diseases other than COPD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01483534

University Medical Center Groningen (UMCG)
Groningen, Netherlands, 9700
South Africa
Panorama Medi-Clinic
Panorama, Cape Town, South Africa
Stellenbosch University
Capetown, South Africa, 7505
Sponsors and Collaborators
Principal Investigator: Dirk-Jan Slebos, MD, PhD University Medical Center Groningen
  More Information

Additional Information:
Responsible Party: Holaira Identifier: NCT01483534     History of Changes
Other Study ID Numbers: CLP-001 
Study First Received: November 29, 2011
Last Updated: February 17, 2016
Health Authority: South Africa: National Health Research Ethics Council
Netherlands: Dutch Health Care Inspectorate

Keywords provided by Holaira:
Chronic Obstructive Pulmonary Disease
Holaira, Inc.
Innovative Pulmonary Solutions, Inc.

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases processed this record on May 25, 2016