Changes in Lung Physiology and Cardiac Performance in Patients With Emphysema Post Bilateral RePneu Coil Treatment

NCT02499380 | Terminated Results

• 1 other identifier: CLN0017
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

The objective of this post-marketing study is to advance the understanding of the mechanism of action of the CE marked RePneu Coil by observing changes in lung physiology and cardiac performance in patients with emphysema treated with the RePneu Coils, when used as intended.

Conditions

Emphysema

Keywords

RePneu; Coil; LVRC; PneumRx

Outcome Measures

Primary Outcomes (2)

• Changes in 6 Minute Walk Distance (6MWD)

  Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 12 months after the initial treatment of the RePneu coil. 6MWD was measured in meters.

  Baseline, 12 months post initial treatment

• Changes in 6 Minute Walk Distance (6MWD)

  Changes in distance traveled during a 6 minute walk test (6MWT). Initial baseline measurement was taken prior to the treatment with the RePneu coil and the second measurement was taken 3 months after final treatment of the RePneu coil. 6MWD was measured in meters.

  Baseline, 3 months post final treatment

Study Arms (1)

Treatment

Patients treated with PneumRx Coil System

Device: PneumRx Coil System

Interventions

PneumRx Coil System DEVICE

Also known as: LVRC, RePneu

Treatment

Eligibility Criteria

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

Study Population

Adult subjects diagnosed with emphysematous type of COPD

You may qualify if:

• Adult subjects diagnosed with emphysematous type of COPD.
• CT scan indicates bilateral emphysema, with sufficient lung parenchyma for coil deployment (based on PneumRx CT scoring) criteria.
• Subject has post-bronchodilator FEV1 ≤45% predicted.
• Subject has Total Lung Capacity \>100% predicted.
• Subject has residual volume (RV) ≥175% predicted.
• Subject has marked dyspnea scoring ≥2 on mMRC scale of 0-4.
• Subject read, understood and signed the Informed Consent form.
• Subject has received Pneumococcal and 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 not due to dyspnea.
• Subject has a change in FEV1 \>20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of \> 200 mL) post-bronchodilator unless investigator can confirm by other means that subject does not have asthma.
• Subject has severe gas exchange abnormalities as defined by:
• PaCO2 \>55 mm Hg
• PaO2 \<45 mm Hg on room air (High altitude criterion: PaO2 \<30 mm Hg)
• Subject has severe pulmonary hypertension defined by right ventricular systolic pressure \>50 mm Hg via right heart catheterization and/or echocardiogram.
• 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 had previous LVR surgery, lung transplantation, lobectomy or other BLVR treatment in either lung.
• Subject has participated in studies to treat COPD using high dose radiation.
• Subject has been involved in pulmonary drug or device studies within 30 days prior to this study.
• Subject is chronically 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

• Boston Scientific Corporation: lead
• PneumRx, Inc.: collaborator

Study Sites (2)

Lungenclinic

Großhansdorf, Germany

Location

Thoraxklinik

Heidelberg, Germany

Location

MeSH Terms

Conditions

Emphysema

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jörg Rennecke
• Organization: PneumRx

medical.services@btgplc.com

+49 211 5422750

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2015
• First Posted: July 16, 2015
• Study Start: June 9, 2015
• Primary Completion: December 8, 2017
• Study Completion: October 20, 2018
• Last Updated: July 19, 2021
• Results First Posted: June 25, 2019

Record last verified: 2021-07

Locations

DE (2)