FindTrial
Sign In

A study to test accuracy of FMRA software in comparison with MRI scan for measuring uterine fibroids.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2021/12/038601
Enrollment
15
Registered
2021-12-14
Start date
Unknown
Completion date
Unknown
Last updated
2024-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: D251- Intramural leiomyoma of uterus

Interventions

Intervention1: NIL: NIL Control Intervention1: NIL: NIL

Sponsors

Nesa Medtech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To assess the time required for annotation in FMRA to generate the 3D rendered representation of the uterus model.Timepoint: At baseline only—

Countries

India

Contacts

Public ContactSreekar Kothamachu

Nesa Medtech Pvt Ltd

lakshmi@nesamedtech.com8073659428

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026