UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019141 |
|---|---|
| Receipt number | R000022127 |
| Scientific Title | Immediate Breast Reconstruction with Brava assisted Fat Grafting following Skin/Nipple-Sparing Mastectomy |
| Date of disclosure of the study information | 2015/09/28 |
| Last modified on | 2024/04/04 13:48:50 |
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Basic information
Public title
Immediate Breast Reconstruction with Brava assisted Fat Grafting following Skin/Nipple-Sparing Mastectomy
Acronym
Immediate Breast Reconstruction with Fat Grafting following Skin/Nipple-Sparing Mastectomy
Scientific Title
Immediate Breast Reconstruction with Brava assisted Fat Grafting following Skin/Nipple-Sparing Mastectomy
Scientific Title:Acronym
Immediate Breast Reconstruction with Fat Grafting following Skin/Nipple-Sparing Mastectomy
Region
| Japan |
Condition
Condition
Early Breast Cancer
Classification by specialty
| Breast surgery | Plastic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy of immediate breast reconstruction with Brava assisted fat grafting following skin/nipple-sparing mastectomy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
1. Postoperative complication
2. Fat graft survival (judge by MRI, one year after the procedure)
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 | Maneuver |
Interventions/Control_1
Immediate Breast Reconstruction with Fat Grafting using Brava system following Skin/Nipple-Sparing Mastectomy
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
| 65 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Breast cancer patients those who considered unnecessary for radiation therapy and/or chemotherapy.
2. Cases expected to preserve skin and subcutaneal tissue.
3. Cases without invasion to pectoral muscle and expected to preserve pectoral muscle.
Key exclusion criteria
4. Cases without severe comorbidities.
5. Cases without history of skin allergy and/or contact allergy.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiko Satake |
Organization
Yokohama City Univercity Medical Center
Division name
Plastic Surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama city, Kanagawa prefecture
TEL
+81-45-261-5656
toshist@zb4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazutaka Narui |
Organization
Yokohama City Univercity Medical Center
Division name
Breast and Thyroid Surgery
Zip code
Address
4-57 Urafune-cho, Minami-ku, Yokohama city
TEL
+81-45-261-5656
Homepage URL
nr1@gc5.so-net.ne.jp
Sponsor or person
Institute
Dept. of Plastic Surgery, Yokohama City Univercity Medical Center
Institute
Department
Personal name
Funding Source
Organization
Yokohama City Univercity Medical Center
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
Address
Tel
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
横浜市立大学付属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
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
| 2013 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2013 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2024 | 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
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022127
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
