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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027742
Receipt No. R000031785
Scientific Title Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
Date of disclosure of the study information 2017/06/13
Last modified on 2018/10/15

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Basic information
Public title Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
Acronym AFLT study for MMK
Scientific Title Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
Scientific Title:Acronym AFLT study for MMK
Region
Japan

Condition
Condition Symptom of vulvovaginal atrophy caused from low estrogen state
Classification by specialty
Obsterics and gynecology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate cancer related low estrogen state and vulvovaginal atrophy and efficacy of AFLT for breast cancer patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by questionnaire
Key secondary outcomes Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by objective evaluation and questionnaire.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 Smarttxide2
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
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria breast cancer patients with vulvovaginal atrophy symptoms
Key exclusion criteria 1) heart disease
2) severely lung disease
3) pelvic organ prolapse (more than 3)
4) pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ninomiya Noriko
Organization Women Clinic LUNA SHINSAIBASHI
Division name Urology
Zip code
Address 1-13-21 Nishi-shinsaibashi Chuoh-ku Osaka
TEL 0662517505
Email ninomiya5829@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ninomiya Noriko
Organization Women Clinic LUNA SHINSAIBASHI
Division name Urology
Zip code
Address 1-13-21 Nishi-shinnsaibashi Chuou-ku
TEL 0662517505
Homepage URL
Email ninomiya5829@yahoo.co.jp

Sponsor
Institute Medical corporation LEADING GIRLS
Institute
Department

Funding Source
Organization DEKA Japan co.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor DEKA Japan co.
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 06 Month 13 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 No longer recruiting
Date of protocol fixation
2017 Year 05 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 14 Day
Last follow-up date
2018 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 13 Day
Last modified on
2018 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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