Innovative Pulmonary Solutions (IPS) System for Targeted Lung Denervation

NCT01483534 | Completed Phase 1 DMC

• 1 other identifier: CLP-001
• Study Type: interventional
• Target: 22
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; Pulmonary; Intervention; Device; Denervation; Lung; Holaira, Inc.; Innovative Pulmonary Solutions, Inc.

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  Safety will be evaluated as freedom from documented and sustained worsening of COPD directly attributable to the investigational device or procedure.

  365 days post procedure

Secondary Outcomes (1)

• Technical Feasibility

  At time of Treatment

Study Arms (1)

Targeted Lung Denervation

EXPERIMENTAL

Targeted Lung Denervation

Device: TLD Therapy (IPS SystemTM)

Interventions

TLD Therapy (IPS SystemTM) DEVICE

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.

Also known as: TLD Therapy, Targeted Lung Denervation Therapy

Targeted Lung Denervation

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuvaira, Inc.: lead

Study Sites (3)

University Medical Center Groningen (UMCG)

Groningen, 9700, Netherlands

Location

Panorama Medi-Clinic

Panorama, Cape Town, South Africa

Location

Stellenbosch University

Capetown, 7505, South Africa

Location

Related Publications (1)

• Slebos DJ, Klooster K, Koegelenberg CF, Theron J, Styen D, Valipour A, Mayse M, Bolliger CT. Targeted lung denervation for moderate to severe COPD: a pilot study. Thorax. 2015 May;70(5):411-9. doi: 10.1136/thoraxjnl-2014-206146. Epub 2015 Mar 4.

  PMID: 25739911 RESULT

Related Links

• Targeted lung denervation for moderate to severe COPD: a pilot study.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dirk-Jan Slebos, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2011
• First Posted: December 1, 2011
• Study Start: October 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2015
• Last Updated: September 23, 2016

Record last verified: 2016-02

Locations

ZA (2); NL (1)