A study to test accuracy of FMRA software in comparison with MRI scan for measuring uterine fibroids.
Not Applicable
Completed
- Conditions
- Health Condition 1: D251- Intramural leiomyoma of uterus
- Registration Number
- CTRI/2021/12/038601
- Lead Sponsor
- esa Medtech Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 15
Inclusion Criteria
1. Women aged 18 to 60, diagnosed with lesser than 3 fibroids, and maximum fibroid size being 5cm
2. Women willing to undergo Transvaginal ultrasound and MRI of Pelvis
3. Women willing to provide consent for participation in this investigation.
Exclusion Criteria
1. Unmarried women
2. Women with Type 0,1,6,7 fibroids as per FIGO classification
3. Women in whom TVS cannot be done due to severe vaginismus/ vaginal stenosis
4. Women who are pregnant
5. Women with endometrial polyps
6. Women with uterus size of >15cm
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the accuracy of size, coordinates of fibroids and uterus dimensions generated by FMRA software w.r.t values interpolated from MRI images.Timepoint: At baseline only
- Secondary Outcome Measures
Name Time Method To assess the time required for annotation in FMRA to generate the 3D rendered representation of the uterus model.Timepoint: At baseline only