Lung Volume Reduction Coil Treatment in Emphysema. (STICREVOLENS)

April 29, 2014 updated by: CHU de Reims

Cost-effectiveness of Lung Volume Reduction Coil Treatment in Emphysema.

  • BACKGROUND: Medical therapeutic options for the treatment of emphysema remain limited. Lung volume reduction surgery is infrequently used because of its high morbi-mortality. Endobronchial lung volume reduction coil (LVRC(®), PneumRx, Mountain View, CA) treatment has been recently developed and has been shown to be feasible and associated with an acceptable safety profile, while resulting in improvements in dyspnea, exercise capacity and lung function. The objective of this study is to analyze the cost effectiveness of LVRC treatment in severe emphysema.
  • METHODS:This prospective, multicenter study, randomized with a 1:1 ratio (LVRC vs conventional treatment) will include 100 patients who will be followed up for 1year. The primary outcome measure is the 6-month improvement of the 6-minute walk test: the percentage of patients showing an improvement of at least 54m will be compared between groups. A cost-effectiveness study will estimate the cost of LVRC treatment, the global cost of this therapeutic option and will compare the cost between patients treated by LVRC and by medical treatment alone.
  • EXPECTED RESULTS:This study should allow validating the clinical efficacy of LVRC in severe emphysema. The cost-effectiveness study will assess the medical-economic impact of the LVRC therapeutic option.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • AMIENS Cedex 1, France, 80054
        • CHU d'Amiens
      • GRENOBLE Cedex 9, France, 38043
        • CHU de GRENOBLE
      • MONTPELLIER Cedex 5, France, 34295
        • CHU de Montpellier
      • Marseille, France, 13015
        • AP-HM
      • Nice, France, 06002
        • Chu De Nice
      • PARIS Cedex 18, France, 75877
        • AP-HP - Hôpital Bichat
      • ROUEN Cedex, France, 76031
        • CHU de Rouen
      • STRASBOURG Cedex, France, 67091
        • Hopitaux Universitaires de Strasbourg
      • Saint-priest-en-jarez, France, 42270
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Bilateral emphysema on Chest CT Scanner
  • Post bronchodilator FEV1 < 50 %
  • Total Lung Capacity > 100 %
  • Residual Volume > 220 %
  • Dyspnea score between 2 and 4 based on the mMRC scale
  • Stopped cigarette smoking for more than 8 weeks
  • Pulmonary rehabilitation within the previous twelve months
  • Consent form signed
  • Covered by Medical Insurance

Exclusion Criteria:

  • Post bronchodilator FEV1 < 15%
  • Post-bronchodilator change in FEV1 > 20%
  • Severe recurrent respiratory infections requiring more than 2 hospitalization stays within the past twelve months
  • COPD exacerbation requiring hospital stay within 3 months
  • Pulmonary Hypertension (Pulmonary systolic pressure >50 mmHg on cardiac echo)
  • Patient unable to perform a 6-min walking test in room air
  • Giant bulla of more than 1/3 of the lung field on Chest CT
  • Strictly homogeneous emphysema on Chest CT
  • Clinically significant bronchiectasis
  • Past history of lobectomy, lung volume reduction surgery, lung transplantation
  • Any extrapulmonary diseases compromising survival or evaluation within the protocol (severe cardiac disease, severe renal insufficiency, cancer…)
  • Lung carcinoma or pulmonary nodule on CT scan requiring Chest CT scan follow-up
  • Contra-indication to general anesthesia
  • Oral anticoagulant treatment (antivitamin K)
  • Allergy to nitinol
  • Inclusion in an other study assessing respiratory treatments
  • Patient protected by the law

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Lung volume reduction coïl treatment
Lung volume reduction coïl treatment,added to usual medical treatment and follow up after the intervention
Procedure: Lung volume reduction coïl treatment
Other: Regular medical treatment
OTHER: Regular Medical Treatment
No intervention, just a follow up under usual medical treatment
Other: Regular medical treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
6-month improvement of the 6-minute walk test
Time Frame: 6 months
6-month improvement of the 6-minute walk test : the percentage of patients showing an improvement of at least 54m will be compared between groups.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Cost-effectiveness
Time Frame: 6 and 12 months
Cost utility (incremental cost effectiveness ratio) of each therapeutic option according to the EuroQol-5 dimensions (EQ-5D) utility scores.
6 and 12 months
Dyspnea
Time Frame: 6 and 12 months
Comparison of dyspnea assessed by the mMRC scale, BDI/TDI scale and the Borg scale
6 and 12 months
Pulmonary function assessment
Time Frame: 6 and 12 months
Pulmonary function tests including FEV1, FVC, RV, TLC, RV/TLC.
6 and 12 months
Quality of life
Time Frame: 6 and 12 months
Comparison of the St georges questionnaire score and the EuroQoL 5D (European Quality of Life 5 dimensions)
6 and 12 months
Morbidity-mortality
Time Frame: 6 and 12 months
Comparison of mortality and severe adverse events using a composite score (death, haemoptysis > 150 cc, pneumonia requiring hospitalization, pneumothorax requiring chest tube drainage > 7 days, mechanical ventilation > 24 hours, lung transplantation).
6 and 12 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Exercise testing
Time Frame: 6 and 12 months months
Comparison of the 6-min walking test between groups (using the > 25 meters change from baseline as cut-off for clinically significant change).
6 and 12 months months
Exercise testing
Time Frame: 12 months
Comparison of the 6-min walking distance at 12 months using 54 meters as cut-off for clinically significant change.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
CHU de Reims

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
PneumRx, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Gaëtan DESLEE, PhD, MD, CHU de Reims

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2013

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2015

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 2, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PD12133

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