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Mapping Uterine Fibroids in reproductive age group of women using a novel software

Evaluating the performance of FMRA for Uterine Fibroid Mapping - NIL

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/09/073766
Enrollment
156
Registered
2024-09-11
Start date
Unknown
Completion date
Unknown
Last updated
2024-12-09

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

Conditions

Health Condition 1: - Health Condition 2: N938- Other specified abnormal uterine and vaginal bleeding

Interventions

Intervention1: Nil: Nil Control Intervention1: Nil: Nil

Sponsors

Nesa MedTech Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1)Women aged 21 and above diagnosed with symptomatic uterine fibroids and/scheduled for transvaginal imaging evaluation. 2)Women willing to provide written informed consent for utilizing related information.

Exclusion criteria

Exclusion criteria: 1)Women in whom TVS cannot be done due to severe vaginismus/ vaginal stenosis. 2)Women with endometrial polyps. 3)Women with uterus size of above to 15cm. 4)FIGO classification type 0 and type 7. 5)Women who are pregnant. 6)Unmarried women.

Design outcomes

Primary

MeasureTime frame
To understand FMRA usability related challengesTimepoint: 3 months—

Secondary

MeasureTime frame
To assess the usability of FMRA in clinical decision support, through questionnaire and 3D model generated from FMRA.Timepoint: 3 months—

Countries

India

Contacts

Public ContactDT Arasu

Nesa Medtech Private Limited

yogithas@nesamedtech.com9019708139

Outcome results

None listed

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