UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043172 |
|---|---|
| Receipt number | R000048375 |
| Scientific Title | Research and development of a simple and non-invasive prosthesis fixation method using a magnetic attachment |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2022/11/14 08:43:51 |
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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
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
kasaisho@med.u-ryukyu.ac.jp
Sponsor or person
Institute
University of the Ryukyus
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048375
