A Safety and Feasibility Study of Re-treating Patients With Severe Emphysema With the RePneu LVRC System.

NCT02012673 | Completed DMC

• 1 other identifier: RECOIL-study
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: The combined data from 3 studies outside the Unites States investigating the Lung Volume Reduction Coil system (RePneu LVRC) showed statistically significant improvements in pulmonary function, exercise capacity and quality of life at both 6-Months and 12-Months post treatment. 24 months post treatment the improved pulmonary function and exercise capacity are slightly decreasing. Retreating the patient with the LVR coil system in other parts of the lung could potentially lead to new improvements in lung function, dyspnea, exercise capacity and quality of life and may reduce the rate of decline. Objective: To investigate the safety and feasibility of re-treating patients with severe Chronic Obstructive Pulmonary Disease (COPD) with the RePneu LVRC system.

Conditions

COPD; Emphysema

Keywords

COPD; Emphysema; Bronchoscopy; Lung Volume Reduction

Outcome Measures

Primary Outcomes (1)

• Number and type of adverse effects as a measure of safety between baseline and 6 months follow up

  The safety objective of this study is to identify the potential number and type of device-related and procedure-related adverse effects.

  Baseline - 6 month follow up

Secondary Outcomes (6)

• Change from Baseline in Lung function at 2 months

  Baseline vs 2 month follow up

• Change from Baseline in Quality of life at 2 months

  Baseline vs 2 month follow up

• Change from Baseline in functional measures at 2 months

  Baseline vs 2 month follow up

• Change from Baseline in Lung function at 6 months

  Baseline vs 6 month follow up

• Change from Baseline in quality of life at 6 months

  Baseline vs 6 month follow up

Study Arms (1)

Bronchoscopic lung volume reduction

EXPERIMENTAL

Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system

Device: Bronchoscopic lung volume reduction

Interventions

Bronchoscopic lung volume reduction DEVICE

Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system. The RePneu LVRC is an implantable device, delivered through a fiber-optic bronchoscope, designed specifically to treat patients suffering from emphysema. The Coil is intended to compress the most damaged parenchyma and tension the surrounding tissue, which increases elastic recoil, reduces hyperinflation and redirects air to healthier portions of the lung for more effective ventilation.

Bronchoscopic lung volume reduction

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Treated with the RePneu LVRC system \> 24 months ago.
• Six months after the first bilateral treatment with the RePneu LVRC system the patient had a significant improvement above the established minimal important difference (MID) of 6-minute walk distance (6MWD: 26 meter) or of forced expiratory volume in 1 second (FEV1: 100ml) or of St. Georges Respiratory Questionnaire total score (SGRQ: 4 points).
• Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
• Subject has stopped smoking for at least 6 months prior to entering the study.
• Subject read, understood and signed the Informed Consent form.
• Subject has completed a pulmonary rehabilitation program within 6 months prior to treatment and/or regularly performing maintenance respiratory rehabilitation if initial supervised therapy occurred more than 6 months prior to baseline testing.
• Subject has received Influenza vaccinations consistent with local recommendations and/or policy.

You may not qualify if:

• Subject has co-morbidities that may significantly reduce subject's ability to improve exercise capacity (e.g., severe arthritis, planned knee surgery) or baseline limitation on 6MWT is not due to dyspnea.
• Subject has severe gas exchange abnormalities as defined by:
• PaCO2 \>8.0 kPa; PaO2 \< 6.0 kPa (room air).
• Subject has a history of recurrent clinically significant respiratory infections, defined as 3 hospitalizations for respiratory infection during the year prior to enrollment.
• Subject has severe pulmonary hypertension defined by right ventricular systolic pressure \>50 mm Hg via echocardiogram.
• Subject has an inability to walk \>140 meters in 6 minutes.
• Subject has evidence of other severe disease (such as, but not limited to, lung cancer or renal failure), which in the judgment of the investigator may compromise survival of the subject for the duration of the study.
• Subject is pregnant or lactating, or plans to become pregnant within the study timeframe.
• Subject has an inability to tolerate bronchoscopy under moderate sedation or general anesthesia.
• Subject has clinically significant bronchiectasis.
• Subject has giant bullae \>1/3 lung volume.
• Subject has had previous LVR surgery, lung transplantation or lobectomy.
• Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
• Subject is taking \>20 mg prednisone (or equivalent dose of a similar steroid) daily.
• Subject requires high level chronic immunomodulatory therapy to treat a moderate to severe chronic inflammatory autoimmune disorder.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, Netherlands

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Interventions

Pneumonectomy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Dirk-Jan Slebos, MD PhD

  University Medical Center Groningen, Department of Pulmonary Diseases

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: December 16, 2013
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: June 27, 2017

Record last verified: 2017-06

Locations

NL (1)