NCT02638688

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 23, 2015

Completed
Last Updated

December 23, 2015

Status Verified

December 1, 2015

Enrollment Period

2.7 years

First QC Date

December 18, 2015

Last Update Submit

December 22, 2015

Conditions

Gynecology

Outcome Measures

Primary Outcomes (1)

  • measuring fibroid volumes

    2012-2015

Study Arms (3)

2D ultrasound

2D-US measurements are the most accurate method for measuring fibroid volumes

Other: ultrasound

3D ultrasound

3D-US measurements are the most accurate method for measuring fibroid volumes

Other: ultrasound

postoperative

actual volume using change in water path measurements are the most accurate method for measuring fibroid volumes

Other: ultrasound

Interventions

ultrasoundOTHER
2D ultrasound3D ultrasoundpostoperative

Eligibility Criteria

Age22 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

44

You may qualify if:

  • surgical intervention

You may not qualify if:

  • unfit for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faculty

Study Record Dates

First Submitted

December 18, 2015

First Posted

December 23, 2015

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

December 23, 2015

Record last verified: 2015-12