Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil

Not Applicable

• Conditions: Chronic obstructive pulmonary disease (COPD)

• Registration Number: JPRN-UMIN000023406
• Lead Sponsor: St. Marianna University School of Medicine

Brief Summary

This is the first report for bronchoscopic lung volume reduction with LVRC in a patient with COPD in Japan. No serious adverse events occurred during procedures and clinical improvements were observed for exercise capacity and the subjective symptoms for this patient.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08-01
• Results First Posted: 2019-01-25
• Study Completion: 2019-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

Exclusion Criteria

1.Extensive emphysema so that only a poor amount tissue can be rolled by LVRC 2.Co-morbidities (e.g.,orthopedic disease or significant cardiovascular disease) that significantly reduce his/her ability to walk, and therefore cannot perform the six-minute walk test (6MWT). 3.A change in FEV1>20% (or, for subjects with pre-bronchodilator FEV1 below 1 L, a change of >200 mL) post-bronchodilator unless the investigator can confirm by other means that subject does not have asthma. 4.%DLco<20% 5.PaO2<45Torr or PaCO2>=55 Torr 6.A history of recurrent clinically significant respiratory infections. 7.Severe pulmonary hypertension. 8.6MWD<=140m. 9.Serious disease that may compromise survival of the subject for the duration of the study. 10.Pregnant or lactating. 11.Not able to tolerate bronchoscopy. 12.Clinically significant bronchiectasis. 13.Giant bullae >=1/3rd one-lung volume. 14.HIstory of LVR surgery (including BLVR) or lobectomy. 15.Involved in pulmonary drug or device studies within 30 days prior to informed consent of the study. 16.Taking>=20 mg prednisone daily, or high-dose chronic immunosuppressive therapy. 17.Antiplatelet agent or anticoagulant therapy that cannot be stopped for 7 days prior to the procedure. 18. Sensitivity or allergy to nickel or other agents or devices used for bronchoscopic therapy. 19. Alpha-1 antitrypsin deficiency. 20.Any other condition that the investigator judges to exclude from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified