UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000022797
Receipt No. 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 2016/06/20

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Obsterics 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 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name shunichiro tsuji
Organization Shiga University of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga
TEL 077-548-2267
Email tsuji002@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shunichiro Tsuji
Organization Shiga University of Medical Science
Division name Department of Obstetrics and Gynecology
Zip code
Address Seta Tsukinowa-cho, Otsu City, Shiga
TEL 077-548-2267
Homepage URL
Email tsuji002@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2015 Year 12 Month 07 Day
Date of IRB
Anticipated trial start date
2015 Year 12 Month 07 Day
Last follow-up date
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
2016 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026274

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.