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A study to assess the cancer of mammary gland using a computer device and compare with traditional method of examination.

A feasibility study comparative study of clinical breast examination vs i Breast exam device as a screening tool in women for early detection of breast cancer at tmh and actrec

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/03/050666
Enrollment
370
Registered
2023-03-14
Start date
Unknown
Completion date
Unknown
Last updated
2023-04-03

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

Conditions

None listed

Interventions

Intervention1: iBreast tool: I-BREAST TOOL Its piezoelectric finger technology measures differences in breast tissue stiffness using tactile palpation from the skin surface. The device is paired wit

Sponsors

Dr Gauri Navalkar Godse
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Women above 30 to 40 years 20% and women above 40 years 80% working at TMH and ACTREC Mumbai hospital. - Women with family history of fibroadenoma -Women patients coming to preventive oncology clinic

Exclusion criteria

Exclusion criteria: -Pregnant or lactating women -Women with history of cancer

Design outcomes

Primary

MeasureTime frame
1.To compare the outcomes of â??intelligent-breast examination to clinical breast examination by estimating sensitivity and specificity of the device using imaging results(Mammography/USG) to be specifiedTimepoint: after taking the first client the outcome will be assessed in 4 weeks—

Secondary

MeasureTime frame
To compare the outcomes of â??intelligent-breast examination to clinical breast examination by estimating sensitivity and specificity of the device using imaging results(Mammography/USG) to be specifiedTimepoint: after taking the first client the outcome will be assessed in 4 weeks—

Countries

India

Contacts

Public ContactMrs sime chacko

TMH college of nursing

manisha.19pawar@gmail.com8850064592

Outcome results

None listed

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