UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043908
Receipt number R000050149
Scientific Title Efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult: a multi-institutional study
Date of disclosure of the study information 2021/04/15
Last modified on 2021/04/13 14:28:44

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Basic information

Public title

Efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult: a multi-institutional study

Acronym

Efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult: a multi-institutional study

Scientific Title

Efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult: a multi-institutional study

Scientific Title:Acronym

Efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult: a multi-institutional study

Region

Japan


Condition

Condition

spontaneous pneumothorax

Classification by specialty

Chest surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Considering of efficacy of absorbable sheet after bullectomy for spontaneous pneumothorax in a young adult

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

recurrence rate and time to recurrence

Key secondary outcomes



Base

Study type

Observational


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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

16 years-old <=

Age-upper limit

30 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients who is under 31 years old, underwent primary thoracoscopic bullectomy with covering sheet for spontaneous pneumothorax

Key exclusion criteria

Patients who are judged ineligible by the in vestigator

Target sample size

500


Research contact person

Name of lead principal investigator

1st name Risa
Middle name
Last name Oda

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Oncology, Immunology and Surgery

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

TEL

0528538231

Email

pear_pear111@yahoo.co.jp


Public contact

Name of contact person

1st name Risa
Middle name
Last name Oda

Organization

Nagoya City University Graduate School of Medical Sciences

Division name

Department of Oncology, Immunology and Surgery

Zip code

467-8601

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

TEL

0528538231

Homepage URL


Email

pear_pear111@yahoo.co.jp


Sponsor or person

Institute

Nagoya City University

Institute

Department

Personal name



Funding Source

Organization

self funding

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

Nagoya City University Graduate School of Medical Sciences

Address

1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya

Tel

0528538231

Email

pear_pear111@yahoo.co.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

60-0-0062

Org. issuing International ID_1

Nagoya City University Graduate School of Medical Sciences

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 04 Month 15 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

400

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

No longer recruiting

Date of protocol fixation

2018 Year 10 Month 01 Day

Date of IRB

2020 Year 08 Month 18 Day

Anticipated trial start date

2018 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 04 Month 13 Day

Last modified on

2021 Year 04 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050149


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name