UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030771 |
|---|---|
| Receipt number | R000035136 |
| Scientific Title | An exploratory clinical trial for the congenital melanocytic nevi using the combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2020/10/03 16:14:44 |
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Basic information
Public title
An exploratory clinical trial for the congenital melanocytic nevi using the combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Acronym
The 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 combination therapy with the inactivated autologous nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Scientific Title:Acronym
The combination therapy with the inactivated nevus tissue by high hydrostatic pressure and the cultured epithelial autograft
Region
| Japan |
Condition
Condition
Congenital 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
Others
Basic objectives -Others
The operability assessment of high hydrostatic pressurization of nevus tissue
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
The epithelialization grafted site at 12 weeks after the implantation
Key secondary outcomes
The operability assessment of high hydrostatic pressurization of nevus tissue
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Apply cultured epidermal autografts and the pressirized nevus 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients with congenital pigmented nevus that can not be excised using the existing treatment
2.The hairy nevus or the nevus with nevus cells in its reticular layer
3.Operable patients
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 in previous clinical trials
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Morimoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
5731010
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 | Naoki |
| Middle name | |
| Last name | Morimoto |
Organization
Kansai Medical University
Division name
Department of Plastic and Reconstructive Surgery
Zip code
5731010
Address
2-5-1 Shin-machi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
http://kmu-prs.adiva.jp/
morimotn@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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
kansai Medical University IRB
Address
2-5-1,Shinmachi,Hirakata City, Osaka
Tel
072-804-2440
rinriirb@hirakata.kmu.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
関西医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
3
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
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 02 | Month | 29 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 29 | Day |
Date trial data considered complete
| 2020 | Year | 10 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 11 | Day |
Last modified on
| 2020 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035136
