UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023406 |
|---|---|
| Receipt number | R000026967 |
| Scientific Title | Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil |
| Date of disclosure of the study information | 2016/08/01 |
| Last modified on | 2022/08/03 11:43:37 |
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Basic information
Public title
Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil
Acronym
LVRC trial
Scientific Title
Bronchoscopic Lung Volume Reduction with Lung Volume Reduction Coil
Scientific Title:Acronym
LVRC trial
Region
| Japan |
Condition
Condition
Chronic obstructive pulmonary disease (COPD)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the efficacy and safety of bronchoscopic lung volume reduction (BLVR) with LVRCs in order to introduce the treatment in Japan.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.Change in FEV1, SGRQ and 6MWT at 6 months after bilateral treatment
2.Adverse Events
Treatment-related serious adverse events mentioned below, occurring from start of treatment to one lung to 6 months after completion of the treatment:
(1)Pneumothorax with air leaks that continue for 7 or more days
(2)Acute exacerbation and respiratory infection requiring hospitalization or prolongation of hospitalization
(3)Respiratory failure that requires mechanical ventilation control for >=24 hours
(4)Hemoptysis (>=300 mL, or requires transfusion)
(5)Treatment-related deaths
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
The placement of LVRC in the target lobe in the bilateral lung
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Subject has read, understood, and signed the informed consent form.
2.Subject is older than or equal to 35 years of age.
3.Computerized tomography (CT) scan indicates bilateral emphysema.
4.Subject has post-bronchodilator forced expiratory volume in first second (FEV1)<=45% predicted.
5.Subject has Total Lung Capacity (TLC)>100% predicted, and has residual volume (RV)>=175% predicted.
6.Subject has marked dyspnea>=2* on the modified Medical Research Council (mMRC) scale.
*mMRC grade 2 is defined as follows:On level ground, walk slower than people of same age because of breathlessness, or I have to stop for breath when walking at my own pace on the level.
7.Subject has declared that he/she has stopped smoking for at least 8 weeks prior to entering the study.
8.Subject is undergoing respiratory rehabilitation, and will continue treatment.
9.Subject is receiving optimal standard of care therapy for their emphysema, including pneumococcal and influenza vaccinations.
Key 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.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
m-mine@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Mineshita |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
044-977-8111
Homepage URL
m-mine@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of St. Marianna University Hospital
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
Tel
044-977-8111
k-sienbu.mail@marianna-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000026967
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.18907/jjsre.41.1_C1
Number of participants that the trial has enrolled
1
Results
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.
Results date posted
| 2022 | Year | 08 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2019 | Year | 01 | Month | 25 | Day |
Baseline Characteristics
A 76-year-old man with severe COPD has been continuously treated at our outpatient department since 2009. His dyspnea symptoms were continued while undergoing triple therapy treatment and rehabilitation.
Participant flow
We performed bronchoscopic lung volume reduction with 12 LVRC (100mm 8, 125mm 4) that were implanted in the right lower lobe. Two months after the initial procedure, 11 LVRC (100mm 4, 125mm 7) were implanted in the left lower lobe.
Adverse events
No severe adverse events.
Outcome measures
Three months after the secondary procedure, the patients' six-minute walk distance improved by 75m and the Modified Medical Research Council dyspnea scale improved from 3 to 2.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 02 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 07 | Month | 30 | Day |
Last modified on
| 2022 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026967
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/08/03 | Coilﾌﾟﾛﾄｺｰﾙ ver4 H30.6.4修正.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2021/08/03 | 別表.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2021/08/03 | １例目データ.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/26967
