UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000008772
Receipt number R000010018
Scientific Title Clinical trial for soft tissue augmentation by autologous fat injection.
Date of disclosure of the study information 2012/10/01
Last modified on 2012/08/26 15:32:36

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Basic information

Public title

Clinical trial for soft tissue augmentation by autologous fat injection.

Acronym

Versatility of autologous fat injection

Scientific Title

Clinical trial for soft tissue augmentation by autologous fat injection.

Scientific Title:Acronym

Versatility of autologous fat injection

Region

Japan


Condition

Condition

soft tissue contour defomities.

Classification by specialty

Plastic surgery

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To describe and evaluate the treatment of soft tissue contour defomities using autologous fat injection.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

improvement of contour defomities.

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -but assessor(s) are blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Application of autologous fat

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

79 years-old >=

Gender

Male and Female

Key inclusion criteria

Patients with breast-conserving surgery, wanted to improve cosmetic with autologous fat injection.
In patients who underwent breast reconstruction using implants to resection, patients improved cosmetics can be expected by autologous fat injection.
In patients with unilateral facial atrophy progression (Rombergs disease), patients who wish to treatment with autologous fat injection.
In patients who were causing soft tissue contour defomities, such as trauma, wanted to improve cosmetic with autologous fat injyction.

Key exclusion criteria

Patients with the sole purpose of aesthetics.
Patients with serious complications.
Patients with collagen disease, diabetes.
Patients in the oral steroid.
Patients of the patient is determined to breast cancer surgery, a high likelihood of recurrence.

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Emiko Aiba

Organization

Juntendo university

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address

3-1-3 Hongo, Bunkyo-ku, Tokyo, 113-0033

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

Juntendo University

Division name

Department of Plastic and Reconstructive Surgery

Zip code


Address


TEL

03-3813-3111

Homepage URL


Email



Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

Juntendo University

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


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

2012 Year 10 Month 01 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

Open public recruiting

Date of protocol fixation

2012 Year 07 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 10 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

2012 Year 08 Month 26 Day

Last modified on

2012 Year 08 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name