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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018644
Receipt No. R000018421
Scientific Title The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
Date of disclosure of the study information 2015/08/11
Last modified on 2021/01/18

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Basic information
Public title The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
Acronym The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
Scientific Title The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
Scientific Title:Acronym The study of assessing the safety of NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
Region
Japan

Condition
Condition breast cancer
Classification by specialty
Breast surgery Plastic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 An evaluation of safety and efficacy of NEOVEIL sheet in immediate two-stage tissue expander/implant based breast reconstruction.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Acute removal rate of expander/implant .
Key secondary outcomes Acute postoperative complication rate
Cosmetic outcome following breast reconstruction
Patient reported outcome

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 Using NEOVEIL sheet in immediate two-stage tissue expander/implant breast reconstruction.
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Patients are scheduled skin sparing mastectomy or nipple sparing mastectomy and immediate two-stage tissue expander/implant reconstruction
Non obesity
Non severe breast ptosis
Non smoker
Patients who received imformed concent and gained agreement by signature.
Key exclusion criteria Inflammatory cancers
Patients who had recieved radiation therapy
before mastectomy.
Patients who take steroids.
Patients who have endocrine disorder.
(including diabetes mellitus)
Patients with a history of collagen disease.
When the doctor considers the patient is not appropriate.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name Satoko
Middle name
Last name Watanabe
Organization Okayama University Hospital
Division name Department of plastic surgery
Zip code 7008558
Address 2-5-1Shikata-cho Kita-ku Okayama-shi Okayama
TEL 086-235-7214
Email pnd689oi@okayama-u.ac.jp

Public contact
Name of contact person
1st name Satoko
Middle name
Last name Watanabe
Organization Okayama University Hospital
Division name Department of plastic surgery
Zip code 7008558
Address 2-5-1Shikata-cho Kita-ku Okayama-shi Okayama
TEL 086-235-7214
Homepage URL
Email pnd689oi@okayama-u.ac.jp

Sponsor
Institute Department of plastic surgery, Okayama University Hospital
Institute
Department

Funding Source
Organization GUNZECo., Ltd.
KYOTO Medical Planning Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Okayama University Hospital
Address 2-5-1Shikata-cho Kita-ku Okayama-shi Okayama
Tel 086-235-6503
Email mae6605@adm.okayama-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 岡山大学病院(岡山県)

Other administrative information
Date of disclosure of the study information
2015 Year 08 Month 11 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 36
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason now writing
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
2015 Year 02 Month 17 Day
Date of IRB
2015 Year 02 Month 17 Day
Anticipated trial start date
2015 Year 02 Month 17 Day
Last follow-up date
2019 Year 12 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
2015 Year 08 Month 11 Day
Last modified on
2021 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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