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

Email

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/

Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name