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Measurement of Fibroid Volume and 2D, 3D US

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02638688
Recruitment Status : Completed
First Posted : December 23, 2015
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Sherin A Shazly, Zagazig University

Tracking Information
First Submitted Date December 18, 2015
First Posted Date December 23, 2015
Last Update Posted Date December 23, 2015
Study Start Date September 2012
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 22, 2015)		 measuring fibroid volumes [ Time Frame: 2012-2015 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Measurement of Fibroid Volume and 2D, 3D US
Official Title Uterine Fibroid Volume After Myomectomy Compared to Pre-operative Measurement by Two and Three-dimensional Ultrasound
Brief Summary Objective: To compare 2-dimensional and 3-dimensional ultrasound measurements with the actual myomas volume after surgical removal, to clinically test the validity and usability of 3D ultrasound technology as opposed to conventional 2D real-time ultrasound and to assess the reliability of different ultrasound methods to measure volume of uterine fibroids.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 44
Condition Gynecology
Intervention Other: ultrasound
Study Groups/Cohorts
  • 2D ultrasound
    2D-US measurements are the most accurate method for measuring fibroid volumes
    Intervention: Other: ultrasound
  • 3D ultrasound
    3D-US measurements are the most accurate method for measuring fibroid volumes
    Intervention: Other: ultrasound
  • postoperative
    actual volume using change in water path measurements are the most accurate method for measuring fibroid volumes
    Intervention: Other: ultrasound
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 22, 2015)		 3
Original Actual Enrollment Same as current
Actual Study Completion Date June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • surgical intervention

Exclusion Criteria:

  • unfit for surgery
Sex/Gender
Sexes Eligible for Study: Female
Ages 22 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02638688
Other Study ID Numbers s.shazly
2011 ( Registry Identifier: sherin )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Sherin A Shazly, Zagazig University
Study Sponsor Zagazig University
Collaborators Not Provided
Investigators Not Provided
PRS Account Zagazig University
Verification Date December 2015