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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023406
Receipt No. 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 2019/08/03

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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
Email 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
Email m-mine@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email 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
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
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
2019 Year 08 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026967

Research Plan
Registered date File name
2021/08/03 Coilプロトコール 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


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