UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038274 |
|---|---|
| Receipt number | R000043624 |
| Scientific Title | Study of the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management. |
| Date of disclosure of the study information | 2019/12/25 |
| Last modified on | 2022/10/13 20:37:16 |
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Basic information
Public title
Study of the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management.
Acronym
Study of the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management.
Scientific Title
Study of the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management.
Scientific Title:Acronym
Study of the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management.
Region
| Japan |
Condition
Condition
endometrial polyp, septate uterus, Asherman's syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigate the efficacy of silicone sheets for prevention of intrauterine adhesions after hysteroscopic management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The degree of intrauterine adhesion at 3 months after hysteroscopic management
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
A silicone plate is placed in the uterine cavity for 2 months after hysteroscopic management.
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
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.endometrial polyp
2.septate uterus
3.Asherman's syndrome (intrauterine adhesions)
Key exclusion criteria
1.Women who don't desire pregnancy
2.Compromized women who have pre-existing disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamada |
Organization
Okayama University Hospital
Division name
Perinatal Center
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kuta-ku, Okayama
TEL
+81-86-235-7320
ykamada@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiko |
| Middle name | |
| Last name | Kamada |
Organization
Okayama University Hospital
Division name
Perinatal Center
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kuta-ku, Okayama
TEL
+81-86-235-7320
Homepage URL
ykamada@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kuta-ku, Okayama
Tel
+81-86-235-6938
mae6605@adm.okayama-u.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
| 2019 | Year | 12 | Month | 25 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 25 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 11 | Day |
Last modified on
| 2022 | Year | 10 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043624
