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

NCT04520152 | Completed DMC

• 1 other identifier: EFFORT
• Study Type: interventional
• Target: 14
• Locations: 2 countries
• Sites: 2

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

Keywords

lung volume reduction; nitinol; device

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Performance - Quality of Life: St George's Respiratory Questionnaire

  3 months

Study Arms (1)

Treatment group

EXPERIMENTAL

Bronchoscopic LTD placement

Device: FreeFlowMedical Lung Tensioning Device

Interventions

FreeFlowMedical Lung Tensioning Device DEVICE

Bronchoscopic lung tensioning device implantation

Treatment group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• 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
• Clinically significant bronchiectasis
• Severe gas exchange abnormalities defined by PaCO2 \> 7.0 kPa (52 mmHg) and/or PaO2 \< 7.0 kPa (52 mmHg) (measured on room air)
• ≥ 10 mg prednisone (or equivalent dose of other corticosteroids) daily
• Inability to walk \> 140 meters in 6 minutes
• Known pulmonary hypertension defined by right ventricular systolic pressure \> 45 mmHg and/or evidence of pulmonary hypertension of right ventricular failure on echocardiogram
• Significant paraseptal emphysema
• Giant bullae (\>1/3 of lung volume)
• Medical history of asthma
• Underwent previous LVRS, lobectomy, pneumonectomy or lung transplant
• Underwent previous treatment with thermal vapor ablation, AeriSeal, Cryospray, endobronchial coils or endobronchial valves (if still implanted)
• Evidence of other disease(s) that have a predicted survival of less than one year
• Inability to tolerate bronchoscopy under general anaesthesia
• 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

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (2)

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

Heidelberg, Baden-Wurttemberg, D-69126, Germany

Location

University Medical Center Groningen

Groningen, 9700RB, Netherlands

Location

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

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

Study Record Dates

• First Submitted: August 17, 2020
• First Posted: August 20, 2020
• Study Start: June 23, 2021
• Primary Completion: November 8, 2023
• Study Completion: November 8, 2023
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1); NL (1)