UMIN-CTR Clinical Trial

Basic information
Public title	Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment
Acronym	Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment
Scientific Title	Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment
Scientific Title:Acronym	Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment
Region	Japan

Condition
Condition	microtia, nipple areola defect, orbital defect
Classification by specialty	Plastic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to develop a simple and non-invasive prosthesis mounting method that combines magnet attachment and taping.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Patient satisfaction after 1, 3 and 6 months of trial. Evaluated by questionnaire.
Key secondary outcomes	Ease of wearing, maintenance stability, skin condition (presence or absence of dermatitis), prosthesis strength

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	Patients use a silicone prosthesis with a magnetic attachment for 6 months. The frequency of use for 6 months is left to the patient (frequency of use is also one of the evaluation items)
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	6 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Patients who undergo plastic surgery at the University of the Ryukyu Hospital in the period of September 2022 after the approval of this examination, hoping for improvement in body surface tissue defects.(Microtia, tissue defect after breast cancer surgery, facial tissue defect after head and neck cancer, etc.). (2)Of the above (1), patients who do not wish to undergo prompt reconstructive surgery or cannot undergo it due to age or comorbidities. (3)Patients aged 6 to 90 years old who are communicative. (4)Patients who can go to the outpatient clinic for 6 months after the start of the study.
Key exclusion criteria	(1)The person does not want to wear the prosthesis. (2)Judgment ability is immature or deteriorated, and there is a risk of accidental ingestion. (3)There is a wound on the part where the prosthesis will be attached. (4)Skin diseases with a high risk of dermatitis (pemphigus, congenital epidermolysis bullosa, etc.).
Target sample size	11

Research contact person
Name of lead principal investigator	1st name Shogo Middle name Last name Kasai
Organization	University of the Ryukyus Hospital
Division name	Department of Plastic Surgery
Zip code	903-0215
Address	207 Uehara Nishihara-cho Nakagami-gun, Okinawa, 903-0215 Japan
TEL	098-895-3331
Email	kasaisho@med.u-ryukyu.ac.jp

Public contact
Name of contact person	1st name Shogo Middle name Last name Kasai
Organization	University of the Ryukyus Hospital
Division name	Department of Plastic Surgery
Zip code	903-0215
Address	207 Uehara Nishihara-cho Nakagami-gun, Okinawa, 903-0215 Japan
TEL	098-895-3331
Homepage URL
Email	kasaisho@med.u-ryukyu.ac.jp

Sponsor
Institute	University of the Ryukyus
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	University of the Ryukyus, Uehara Campus
Address	207 Uehara Nishihara-cho Nakagami-gun, Okinawa, 903-0215 Japan
Tel	098-895-1542
Email	krinken@acs.u-ryukyu.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

Other administrative information
Date of disclosure of the study information	2021 Year 02 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	8
Results	No adverse events were observed during the all-subject period. Patients with orbital defects had difficulty maintaining adhesion and could not complete the 6-month trial period. Patients with microtia completed the trial period, but it was still difficult to maintain adhesion, and the degree of satisfaction was low. Although there were individual differences in the degree of satisfaction among the areola and nipple patients, some patients had a high degree of satisfaction.
Results date posted	2022 Year 11 Month 14 Day
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	2020 Year 08 Month 07 Day
Date of IRB	2021 Year 01 Month 21 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2022 Year 08 Month 25 Day
Date of closure to data entry	2022 Year 09 Month 22 Day
Date trial data considered complete	2022 Year 09 Month 22 Day
Date analysis concluded	2022 Year 09 Month 22 Day

Other
Other related information

Management information
Registered date	2021 Year 01 Month 29 Day
Last modified on	2022 Year 11 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048375