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Clinical Trials/CTRI/2021/12/038601
CTRI/2021/12/038601
Completed
未知

A comparative study to validate the accuracy of fibroid mapping reviewer application (FMRA) obtained from 2D ultrasound scan versus MRI in fibroid mapping and measurement.

esa Medtech Pvt Ltd0 sites15 target enrollmentTBD

Overview

Phase
未知
Intervention
Not specified
Conditions
Health Condition 1: D251- Intramural leiomyoma of uterus
Sponsor
esa Medtech Pvt Ltd
Enrollment
15
Status
Completed
Last Updated
last year

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
March 31, 2023
Last Updated
last year
Study Type
Observational

Investigators

Sponsor
esa Medtech Pvt Ltd

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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