UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018644 |
|---|---|
| Receipt number | 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 17:56:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
pnd689oi@okayama-u.ac.jp
Sponsor or person
Institute
Department of plastic surgery, Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.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 |
