UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031348
Receipt number R000035762
Scientific Title Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study .
Date of disclosure of the study information 2018/02/17
Last modified on 2019/01/07 17:53:08

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Basic information

Public title

Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study .

Acronym

Efficacy and safety of TissuePatch for air leaks after thoracic surgery

Scientific Title

Efficacy and safety of TissuePatch for air leaks after thoracic surgery: a prospective, randomized, study .

Scientific Title:Acronym

Efficacy and safety of TissuePatch for air leaks after thoracic surgery

Region

Japan


Condition

Condition

lung tumor or pneumothorax

Classification by specialty

Surgery in general Chest surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate efficacy and safety of TissuePatch for air leak after lung resection

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Duration of air leak after procedure

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Device,equipment

Interventions/Control_1

TissuePatch

Interventions/Control_2

Polyglycolic acid sheet and fibrin glue

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

all patients older than 20 who undergo lung surgery

Key exclusion criteria

severe complications, psychiatric disorder, a woman desired pregnancy or during pregnancy or lactation, urgent surgery, others judged as inappropriate

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takahiro Homma

Organization

University of Toyama

Division name

Department of General Thoracic and Cardiovascular Surgery

Zip code


Address

2630 Sugitani, Toyama, Toyama, Japan

TEL

076-434-7330

Email

hommat@med.u-toyama.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takahiro Homma

Organization

University of Toyama

Division name

Department of General Thoracic and Cardiovascular Surgery

Zip code


Address

2630 Sugitani, Toyama, Toyama, Japan

TEL

076-434-7330

Homepage URL


Email

geka1@med.u-toyama.ac.jp


Sponsor or person

Institute

University of Toyama

Institute

Department

Personal name



Funding Source

Organization

Toyama Prefecture Citizens' Personal Development Foundation (TPCPDF)

Organization

Division

Category of Funding Organization

Local Government

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2018 Year 02 Month 17 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


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

Completed

Date of protocol fixation

2018 Year 02 Month 01 Day

Date of IRB


Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 17 Day

Last modified on

2019 Year 01 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035762


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name