Unique ID issued by UMIN | UMIN000027742 |
---|---|
Receipt number | 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 | 2021/06/16 14:31:16 |
Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
AFLT study for MMK
Safety and efficacy of ablative fractional CO2 laser thrapy for external genital and the vagina in women with breast cancer
AFLT study for MMK
Japan |
Symptom of vulvovaginal atrophy caused from low estrogen state
Obstetrics and Gynecology | Urology |
Malignancy
NO
To evaluate cancer related low estrogen state and vulvovaginal atrophy and efficacy of AFLT for breast cancer patients
Safety,Efficacy
Exploratory
Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by questionnaire
Effect of AFLT on breast cancer patients at pre, 3 months, 6 months and one year by objective evaluation and questionnaire.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Self control
1
Treatment
Device,equipment | Maneuver |
Smarttxide2
20 | years-old | <= |
Not applicable |
Female
breast cancer patients with vulvovaginal atrophy symptoms
1) heart disease
2) severely lung disease
3) pelvic organ prolapse (more than 3)
4) pregnancy
20
1st name | Noriko |
Middle name | |
Last name | Ninomiya |
Women Clinic LUNA SHINSAIBASHI
Urology
5420086
1-13-21 Nishi-shinsaibashi Chuoh-ku Osaka
0662517505
ninomiya5829@yahoo.co.jp
1st name | Noriko |
Middle name | |
Last name | Ninomiya |
Women Clinic LUNA SHINSAIBASHI
Urology
5420086
1-13-21 Nishi-shinnsaibashi Chuou-ku
0662517505
ninomiya5829@yahoo.co.jp
Medical corporation LEADING GIRLS
DEKA Japan co.
Profit organization
DEKA Japan co.
Medical corporation LEADING GIRLS
2-96 Motomachi nakaku Yokohama city
045-680-1226
luna.makiskgc@gmail.com
NO
2017 | Year | 06 | Month | 13 | Day |
no
Unpublished
no
7
Vaginal discomfort improved in all treated patients. The improvement in urinary tract symptoms was not significant, but in some patients there was a dramatic improvement.
No serious side effects were observed.
2021 | Year | 06 | Month | 16 | Day |
Women in their 50s or older with a history of breast cancer with one or more vaginal symptoms.
Irradiate the vagina and vulva with a fractional CO2 laser every 4 weeks
Irradiation 3 times in total
Evaluation is performed before the start of irradiation and one month after irradiation.
Pain during and after the procedure
Vaginitis
Vaginal health index
OABSS
Completed
2017 | Year | 05 | Month | 24 | Day |
2017 | Year | 06 | Month | 14 | Day |
2017 | Year | 06 | Month | 14 | Day |
2018 | Year | 09 | Month | 30 | Day |
2019 | Year | 04 | Month | 30 | Day |
2019 | Year | 09 | Month | 30 | Day |
2020 | Year | 04 | Month | 30 | Day |
nothing
2017 | Year | 06 | Month | 13 | Day |
2021 | Year | 06 | Month | 16 | Day |
Value
https://center6.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 |