Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema (EFFORT)

Evaluation of the Free Flow Medical Lung Tensioning Device System for the Treatment of Severe Emphysema - EFFORT

Patients with severe emphysema have limited options for treatment. Current treatments include lung transplant, lung volume reduction surgery or endobronchial lung volume reduction using valves or coils. These options are only available for a small and selected group of patients. The Free Flow Medical Lung Tensioning Device System (LTD) is thought to be the next generation endobronchial treatment for patients with severe emphysema designed to address this unmet need. The LTD is designed to compress the areas of lung parenchyma most damaged by emphysema and to tension surrounding tissue to help restore lung elastic recoil in a similar manner to the lung volume reduction coils.

Study Overview

• Status: Completed
• Conditions: Emphysema or COPD
• Intervention / Treatment: Device: FreeFlowMedical Lung Tensioning Device

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, D-69126
      • Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg
• Netherlands
  • Groningen, Netherlands, 9700RB
    • University Medical Center Groningen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Diagnosis of COPD
2. FEV1/FVC ≤ 70%
3. ≥ 40 years of age
4. Post-bronchodilator FEV1 ≤ 45% of predicted
5. Total Lung Capacity > 100% of predicted
6. Residual Volume (RV) > 175% of predicted
7. RV/TLC > 55%
8. Marked dyspnea defined by a score of ≥ 2 on mMRC dyspnea scale of 0-4
9. Emphysema with ≥ 20% destruction (on -950 Hounsfield units) of two potential treatment lobe(s)
10. Stopped smoking for ≥ 6 months prior to entering the study
11. Completed a pulmonary rehabilitation program prior to entering the study and/or have regular (at least once a week) physiotherapy
12. Ability to read, understand and sign the informed consent form

Exclusion Criteria:

1. History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 2 hospitalizations for respiratory infections and/or COPD exacerbations during the year prior to enrolment
2. History of recurrent clinically significant respiratory infections and/or COPD exacerbations, defined as ≥ 3 courses of prednisolone and/or antibiotics for respiratory infections and/or COPD exacerbations during the year prior to enrolment
3. Clinically significant bronchiectasis
4. Severe gas exchange abnormalities defined by PaCO2 > 7.0 kPa (52 mmHg) and/or PaO2 < 7.0 kPa (52 mmHg) (measured on room air)
5. ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
6. Inability to walk > 140 meters in 6 minutes
7. Known pulmonary hypertension defined by right ventricular systolic pressure > 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
8. Significant paraseptal emphysema
9. Giant bullae (>1/3 of lung volume)
10. Medical history of asthma
11. Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
12. Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
13. Evidence of other disease(s) that have a predicted survival of less than one year
14. Inability to tolerate bronchoscopy under general anaesthesia
15. Maintenance antiplatelet (except aspirin/Ascal) or anticoagulant therapy (such as warfarin, Coumadin, heparin, LMWH, DOACs, etc) which cannot be permanently stopped prior to entering the study
16. Pregnant, lactating or plans to become pregnant within the study timeframe
17. Known sensitivity to drugs required to perform bronchoscopy under general anaesthesia
18. Any other disease, condition(s) or habit(s) that would interfere with completion of study and follow up assessments, would increase risks of bronchoscopy or assessments or in the judgment of the investigator would potentially interfere
19. Known Nickel, Titanium, or Nitinol allergy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; Bronchoscopic LTD placement	Device: FreeFlowMedical Lung Tensioning Device; Bronchoscopic lung tensioning device implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: type and frequency of device-related and procedure-related AE	To evaluate the safety of the LTD in COPD patients with heterogeneous and homogeneous emphysema by evaluating the type and frequency of device-related and procedure-related AE experienced during and following LTD placement through the 3-month visit.	3 months
Procedural succes	To evaluate the feasibility of the LTD in COPD patients with heterogeneous and homogeneous emphysema by measuring the frequencies of successful and unsuccessful intended LTD placements.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performance - Quality of Life: St George's Respiratory Questionnaire	Change in St George's Respiratory Questionnaire total score	3 months

Collaborators and Investigators

• Sponsor: University Medical Center Groningen

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2021
• Primary Completion (Actual): November 8, 2023
• Study Completion (Actual): November 8, 2023

Study Registration Dates

• First Submitted: August 17, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 20, 2020

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: device; lung volume reduction; nitinol
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Chronic Disease; Pulmonary Emphysema; Emphysema
• Other Study ID Numbers: EFFORT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No