UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025868 |
|---|---|
| Receipt number | 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 04:19:44 |
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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
| Obstetrics 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
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
ayman.dawood@med.tanta.edu.eg
Sponsor or person
Institute
Tanta University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029724
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