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

NCT ID: NCT04520152

Last Updated: 2023-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-23
• Study Completion Date: 2023-11-08

Brief Summary

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.

Conditions

Emphysema or COPD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Bronchoscopic LTD placement

Group Type: EXPERIMENTAL

FreeFlowMedical Lung Tensioning Device

Intervention Type: DEVICE

Bronchoscopic lung tensioning device implantation

Interventions

FreeFlowMedical Lung Tensioning Device

Bronchoscopic lung tensioning device implantation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Medical Center Groningen

OTHER

Sponsor Role: lead

Responsible Party

Dirk-Jan Slebos

Prof. dr. D.J. Slebos MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dept. of Pneumology and Critical Care Medicine, Thoraxklinik, University of Heidelberg

Heidelberg, Baden-Wurttemberg, Germany

University Medical Center Groningen

Groningen, , Netherlands

Countries

Germany; Netherlands

Other Identifiers

EFFORT

Identifier Type: -

Identifier Source: org_study_id