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Emphysema clinical trials

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NCT ID: NCT06349174 Not yet recruiting - Clinical trials for Chronic Obstructive Pulmonary Disease

Safety and Efficacy of Endobronchial Valve for Bronchoscopic Lung Volume Reduction Surgery: A Prospective Pilot Study

Start date: April 11, 2024
Phase: N/A
Study type: Interventional

The goal of this pliot study al is to preliminarily evaluate the effectiveness and safety of transbronchial lung volume reduction surgery using the self-devloped endobronchial valves for chronic obstructive pulmonary disease patients with emphysema phenotype . The main questions it aims to answer are: Does self-devloped endobronchial valves improve the lung function、exercise capacity and symptons of participants? What surgery-related adverse events do participants have after transbronchial lung volume reduction surgery using the self-devloped endobronchial valves? Participants will: undergo transbronchial lung volume reduction surgery using the self-devloped endobronchial valves. receive follow-up before surgery (baseline) and 3 days, 4 weeks, 12weeks after surgery.

NCT ID: NCT06181357 Not yet recruiting - COPD Clinical Trials

Trial Evaluating the Rate of Pneumothorax in Severe Emphysema Secondary to Endoscopic Volume Reduction With Two-stage ZEPHYR® Valves Versus Endoscopic Volume Reduction With One-stage ZEPHYR® Valves

REPEAT
Start date: April 15, 2024
Phase: N/A
Study type: Interventional

Chronic obstructive pulmonary disease (COPD) affects 3.5 million people and is the third leading cause of death worldwide. Emphysema involves air retention in the lungs and is ultimately responsible for a major deterioration in the quality of life. Available drug treatments have moderate efficacy whereas surgical lung volume reduction can improve exercise capacity when offered to a very selected population but at the cost of significant morbidity and mortality. Endoscopic Lung Volume reduction with ZEPHYR® valves improves respiratory function at rest, exercise tolerance and quality of life in patients with little or no interlobar collateral ventilation. If this technique has therefore proven its effectiveness, it is not devoid of complications and is notably responsible for pneumothorax in 27% of cases. The management of this complication is clearly codified, ranging from patient monitoring to the removal of one or more valves. It is therefore a subject of major concern for multiple reasons: high incidence, lengthening of hospital stay, increase in the overall cost of care, potential loss of benefit for the patient in the event of permanent withdrawal. valves and above all a potentially fatal event. A new strategy for implanting ZEPHYR® valves in two stages has been developed in Limoges University Hospital. This innovative algorithm has been evaluated in several non-comparative single or multicenter studies. In those studies, pneumothorax' rate secondary to lung volume reduction with endobronchial valves is rated between 4.5 and 12%. The efficacy of the treatment appears to be comparable with the data found in the trials evaluating in which the entire lobe was treated in one procedure. Moreover, despite two procedures, there does not seem to be any increased risk of occurrence of other complications. Finally, the systematic scheduling of a thoracic computed tomography between the two procedures showed that 26.6% of patients presented a reduction in volume greater than 350mL despite incomplete treatment. These data seem promising but no direct comparison with standard one-step treatment has ever been conducted so far.

NCT ID: NCT06152107 Not yet recruiting - Severe Emphysema Clinical Trials

A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema

BTVA
Start date: November 26, 2023
Phase: N/A
Study type: Interventional

To compare the efficacy and safety of subsegmental treatment and segmental treatment with InterVapor in patients with severe emphysema

NCT ID: NCT06025500 Not yet recruiting - Emphysema Clinical Trials

Analysing Peripheral Skeletal Muscle Function Before and After Endobronchial Valve Treatment

ENDURANCE
Start date: March 1, 2024
Phase:
Study type: Observational

Rationale: Chronic obstructive pulmonary disease (COPD) is characterised by a high prevalence of peripheral muscle dysfunction, which can have significant clinical consequences, including decreased exercise capacity, reduced quality of life, and even a higher mortality rate. Reduction of lung hyperinflation using bronchoscopic lung volume reduction treatment with one-way endobronchial valves (EBV) is a minimally invasive intervention which improves exercise capacity and physical activity in patients with severe emphysema. This positive effect is also related to weight gain and alterations in body composition. The physiologic and structural adaptations of skeletal muscle function after EBV treatment has never been investigated before. Objective: To investigate the physiological and structural adaptations of peripheral muscle function at a cellular level in response to EBV treatment. Study design: A single center, prospective clinical trial with a single-arm pretest-posttest design. Patients with severe emphysema who will receive a bronchoscopic lung volume reduction treatment are asked to undergo additional in-magnet exercise testing and muscle biopsies before and after placement of EBVs. Study population: Patients with severe emphysema who are scheduled to undergo EBV treatment. Main study parameters/endpoints: The difference in quadriceps phosphocreatine concentration (PCr), quadriceps inorganic phosphorus concentration (Pi), and quadriceps pH at rest, during progressive exercise, and recovery rate will be measured by 31P-MRS to assess the physiological effect of EBV treatment on skeletal muscle function and its bioenergetics. Furthermore, we will perform a detailed histological and biochemical analysis of muscle fiber type composition, mitochondrial density, master regulators of muscle oxidative programming, and mitochondrial respiration before and after EBV treatment.

NCT ID: NCT05900544 Not yet recruiting - Coronary Disease Clinical Trials

Maximizing Benefit of Lung Cancer Screening Incidental Findings of Cardiovascular, Respiratory and Breast Measures

Start date: October 2024
Phase: N/A
Study type: Interventional

The investigators will implement a patient-centered outcomes tool for participants in lung cancer screening programs that receive clinically important incidental findings relevant to heart, breast and lung health. The study objective is to evaluate participant response and clinical follow-up following implementation of a patient-centered incidental findings communication tool.

NCT ID: NCT05897424 Not yet recruiting - Emphysema Clinical Trials

Open Label Extension Study of INBRX-101 in Adults With AATD Emphysema

ELEVAATE OLE
Start date: June 2024
Phase: Phase 2
Study type: Interventional

Phase 2 open label extension study to evaluate INBRX-101 in adults with AATD emphysema

NCT ID: NCT05717192 Not yet recruiting - Clinical trials for Emphysema or Chronic Obstructive Pulmonary Disease

BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).

NCT ID: NCT05550844 Not yet recruiting - Emphysema Clinical Trials

EMPHYSEMA AND FLNA MUTATION

E-FNLA
Start date: February 2023
Phase:
Study type: Observational

Some sparse scientific data support the hypothesis that otherwise unexplained emphysema may be associated with FLNA mutation. This prospective, monocentric, cross-sectional study aimed to describe the frequency of emphysema in patients carrying an FLNA mutation. Patients with FLNA mutations who accept the study will benefit from a chest physician's clinical examination, respiratory function tests and a chest scan. The primary endpoint is to describe emphysema's frequency in patients carrying FLNA mutation. The other objectives are to describe emphysema's features in these patients and to describe their lung function abnormalities. The final goal is to confirm the association between unexplained emphysema and FLNA mutation.

NCT ID: NCT05118269 Not yet recruiting - Emphysema Clinical Trials

A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial

Start date: July 2023
Phase: N/A
Study type: Interventional

This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.

NCT ID: NCT01758055 Not yet recruiting - Emphysema Clinical Trials

Safety Study of Endobronchial Transplantation of Autologous Mesenchymal Stem Cells (MSCs) in Emphysema Patients

Start date: December 2012
Phase: Phase 1
Study type: Interventional

The purpose of this study is evaluating the safety of endobronchial transplantation of autologous mesenchymal stem cells derived bone marrow in patients with emphysema.