JPRN-UMIN000023406Completed未知
Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil - LVRC trial
St. Marianna University School of Medicine0 sites1 target enrollmentStarted: August 1, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Enrollment
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 35years-old to ot applicable (—)
- Sex
- All
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.
Investigators
Similar Trials
Unknown
Phase 1
Bronchoscopic Thermal Saline Ablation (BTSA) of Emphysematous Lung. A New Emphysema TherapyEmphysemaNCT01920321Assaf-Harofeh Medical Center20
Completed
Not Applicable
Bronchoscopische Longvolume Reductie door middel van éénrichtingsventielen in patiënten met ernstig COPD.NL-OMON23581MC-Groningen, Pulmonary diseases68
Recruiting
Not Applicable
Bronchoscopic EmphysemA Treatment in THE NetherLandsCOPDNCT02815683University Medical Center Groningen500
Unknown
Not Applicable
Lung Volume Reduction Via Coils in Patients With COPDChronic Obstructive Pulmonary Disease (COPD)NCT02246569RWTH Aachen University20
Recruiting
Not Applicable
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using ThermoablationEmphysema or Chronic Obstructive Pulmonary DiseaseNCT05717192IHF GmbH - Institut für Herzinfarktforschung224