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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025868
Receipt No. R000029724
Scientific Title A novel technique for hysteroscopic sterilization: Phase II clinical trial
Date of disclosure of the study information 2017/03/31
Last modified on 2017/01/27

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Basic information
Public title A novel technique for hysteroscopic sterilization: Phase II clinical trial
Acronym A novel technique for hysteroscopic sterilization: Phase II clinical trial
Scientific Title A novel technique for hysteroscopic sterilization: Phase II clinical trial
Scientific Title:Acronym A novel technique for hysteroscopic sterilization: Phase II clinical trial
Region
Africa

Condition
Condition finished
Classification by specialty
Obsterics and gynecology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of mini-loop insert as a sheep practical alternative to the costly Essure in low resources countries
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes success in bilateral insertion of mini-loop insert in both ostia of Fallopian tubes
Key secondary outcomes Postoperative complications,Success rate , state of tubal block in HSG, and acceptability of method by patients

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 Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Placement of mini-loop insert at both tubal ostia through hysteroscopic guidance
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
32 years-old <=
Age-upper limit
45 years-old >=
Gender Female
Key inclusion criteria Unsuitable patients for laparoscopic sterilization
Patients with frozen pelvis
General contraindications for surgery
Failed other contraceptive methods
Key exclusion criteria Refusal of this type of contraception
Current chronic pelvic pain
menstrual irregularities
Cupper allergy
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ayman Shehata Dawood
Organization Tanta University
Division name Ayman Shehata Dawood
Zip code
Address Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, Egypt
TEL 00201020972067
Email ayman.dawood@med.tanta.edu.eg

Public contact
Name of contact person
1st name
Middle name
Last name Ayman Shehata Dawood
Organization Tanta University
Division name Ayman Shehata Dawood
Zip code
Address Tanta University, Faculty of Medicine, Department of Obstetrics and Gynecology, Tanta, Al Gharbia, E
TEL 00201020972067
Homepage URL
Email ayman.dawood@med.tanta.edu.eg

Sponsor
Institute Tanta University
Institute
Department

Funding Source
Organization Tanta University
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
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 03 Month 31 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 07 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 07 Month 01 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
2017 Year 01 Month 27 Day
Last modified on
2017 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029724

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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