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Study that compares Prostate Volume Measured by the ProstaMetrix System with Ultrasound.

A Prospective Blinded, Single-Armed Study Comparing Prostate Volume Measured by the Prostametrix System with Transrectal Ultrasound.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036602
Enrollment
85
Registered
2021-09-17
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: R398- Other symptoms and signs involvingthe genitourinary system

Interventions

Intervention1: ProstaMetrix, Trans Rectal Volumetric measurement with DRE: The device uses an encoder which is used similar to a DRE and is connected to a controller which displays the prostate volume

Sponsors

MedicaMetrix Devices Pvt Ltd
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Male age between 45 and 85 scheduled for TRUS and DRE as part of his clinical work-up for prostate disease

Exclusion criteria

Exclusion criteria: Inability to perform the rectal examination Lower Urinary Tract congenital abnormalities Inability to understand or refusal to grant Informed Consent

Design outcomes

Primary

MeasureTime frame
The percent difference beween Transrectal Ultrasound and ProstaMetrix Volume measurements will be characterized with 95 percent confidence intervalsTimepoint: Real-time—

Secondary

MeasureTime frame
Improve screening and diagnosis using PSA Density. Improve the quality of follow up for patients being treated for Prostate cancerTimepoint: 6 months—

Countries

India

Contacts

Public ContactJyothi Darse

Muljibhai Patel Urological Hospital

akrastogi@mpuh.org

Outcome results

None listed

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