UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022797 |
|---|---|
| Receipt number | R000026274 |
| Scientific Title | A study of pathophysiology in patients with Cesarean Scar Syndrome |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2020/06/25 09:44:32 |
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Basic information
Public title
A study of pathophysiology in patients with Cesarean Scar Syndrome
Acronym
A study of pathophysiology in patients with Cesarean Scar Syndrome
Scientific Title
A study of pathophysiology in patients with Cesarean Scar Syndrome
Scientific Title:Acronym
A study of pathophysiology in patients with Cesarean Scar Syndrome
Region
| Japan |
Condition
Condition
Cesarean Scar Syndrome
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To reveal the pathophysiology in patients with Cesarean Scar Syndrome
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The factor which participates in Cesarean Scar Syndrome
Key secondary outcomes
The efficacy of resectoscopic surgery for Cesarean Scar Syndrome
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
| Maneuver |
Interventions/Control_1
resectoscopic surgery, magnetic resonance
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients was diagnosed in Cesarean Scar Syndrome
Normal women following cesarean scar was not diagnosed in Cesarean Scar Syndrome
Patients who have signed to an approved informed consent.
Key exclusion criteria
Patients who cannot signed an informed consent.
Patients who are difficult to consent.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Murakami |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City, Shiga
TEL
077-548-2267
tsuji002@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Shunichiro |
| Middle name | |
| Last name | Tsuji |
Organization
Shiga University of Medical Science
Division name
Department of Obstetrics and Gynecology
Zip code
5202192
Address
Seta Tsukinowa-cho, Otsu City, Shiga
TEL
077-548-2267
Homepage URL
tsuji002@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee in Shiga University of Medical Scinece
Address
Seta-Tsukinowa-cho, Otsu city, Shiga, Japan
Tel
077-548-3576
hqrec@belle.shiga-med.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
| 2016 | Year | 07 | 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
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
Completed
Date of protocol fixation
| 2015 | Year | 12 | Month | 07 | Day |
Date of IRB
| 2015 | Year | 12 | Month | 07 | Day |
Anticipated trial start date
| 2015 | Year | 12 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2016 | Year | 06 | Month | 20 | Day |
Last modified on
| 2020 | Year | 06 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026274
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
