UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020732 |
|---|---|
| Receipt number | R000022198 |
| Scientific Title | An exploratory clinical trial for the congenital melanocytic nevi using the noble combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft |
| Date of disclosure of the study information | 2016/01/26 |
| Last modified on | 2019/01/26 15:46:19 |
* 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
An exploratory clinical trial for the congenital melanocytic nevi using the noble combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Acronym
The noble combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Scientific Title
An exploratory clinical trial for the congenital melanocytic nevi using the noble combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Scientific Title:Acronym
The noble combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Region
| Japan |
Condition
Condition
Melanocytic nevi
Classification by specialty
| Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Exploration of the take of the pressurized nevus in comnination with the cultured epidermal autograft
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
The take of inactivated nevus with cultured epidermal autograft at 8weeks after implantation
Key secondary outcomes
Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Apply cultured epidermal autografts on the pressirized nevusApply on the wound after the removal of the nevus
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
| 7 | months-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with congenital pigmented nevus that can not be excised and sutured primarily
2.The area of the nevus is more than 0.25% of the body surface area
3.Operable patients more than 7 months old and
4.Written informed consent
Key exclusion criteria
1.Patients with scar tissue that prevent the take of inactivated nevus
2.The nevus that has been treated by cultured epidermal autografts already.
3.A history of malignant tumor with disease free interval of 5 years or less
4.Other patients judged by the
investigator or sub-investigator to be inappropriate as a subject of this study.
5.Patients who have received this protocol treatments twice.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoki Morimoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
morimotn@hirakata.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Omura Miyuki |
Organization
Kansai Medical University
Division name
Center for Clinical Research
Zip code
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
http://www5.kmu.ac.jp/prs/index.html
kmuccr@hirakata.kmu.ac.jp
Sponsor or person
Institute
Department of Plastic and Reconstructive Surgery, Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
関西医科大学附属枚方病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 26 | 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
| 2016 | Year | 01 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 25 | Day |
Last modified on
| 2019 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022198
