Details of Amended Protocol Version 2.0

Protocol No: PHUS-001-2021Version No. 1.0, Dated 16 Aug 2021

Protocol No: PHUS-001-2021 Version No. 2.0, Dated 13 Mar 2025

PHUS-001-2021 Version No. 1.0, Dated 16 Aug 2021

PHUS-001-2021 Version No. 2.0., Dated 13 Mar 2025

In the previous version No.1.0, it was read as -Philips India Ltd. Philips Innovation Campus, MFAR Manyata Tech Park, Nagawara, Bangalore-560045,  India

In the Current Version No.2.0, in this it is added as - Philips Innovation campus, Embassy Business hub, Khata No. 1368/25/2/25/3, Venkatala village, Bangalore North Taluk, Bangalore -560064

In the previous version No.1.0, CRO Address it was read as –

No. 252, 13^th Cross, Wilson Garden, Bangalore-560027

In the Current Version No.2.0, CRO Address in this it is added as -Krishna Arcade, 3rd Floor, #23, 5th Main, 12th Cross, Wilson Garden, Hombegowda Nagar, Bangalore-560027

Inclusion Criteria

In the previous version No.1.0, it was read as_

Subjects must be willing and capable of providing informed consent and physically capable of performing study related activities.            

Subjects 18 years of age including either sex.

Subjects has passed a general medical health checkup.

In the Current Version No.2.0, in this it is added as –

Subjects must be willing and capable of providing informed consent and physically capable of performing study related activities

Subjects 19 years of age including either gender.

 Pregnant females must be 19 years old to be eligible for recruitment for pregnancy ultrasound scans

 Pregnant women with a gestational age of 7 weeks at the time of screening.

Subjects have passed a general medical health checkup

Exclusion Criteria

In the previous version No.1.0, it was read as_

Subjects not willing to sign the ICF or give the consent.

Subjects with a limited capacity or critically ill (e.g. non-ambulatory, admitted in some clinical facility).

Need interventional procedure.

Subjects with mental illness or diseases.Subjects with uncontrolled hypertension and diabetic mellitus

In the Current Version No.2.0, in this it is added as –

Subjects not willing to sign the ICF or give the consent.

Subjects with a limited capacity or critically ill (e.g. nonambulatory, admitted in some clinical facility).  Need interventional procedure.

Subjects with mental illness or diseases.

Subjects with uncontrolled hypertension and diabetic mellitus.

Pregnant women age below 19 yrs.

Pregnant women with a gestational age of 7 weeks at the time of screening

 Philips employees and their close family members are excluded only to prevent coercion.

Background Introduction

NA

In the Current Version No.2.0, in this it is added as -In this study a transvaginal ultrasound is also planned for internal scan of the female reproductive organs. It is an invasive procedure involves inserting a small ultrasound probe into the vagina to produce incredibly detailed images of the organs in the pelvic region. It may be necessary to use a transvaginal ultrasound to examine the: vagina, cervix, uterus, fallopian tubes, ovaries, bladder. The frequency range of a transvaginal transducer is typically in the 5-12 MHZ and given this high resolution, effective imaging to a 7-10 cm range can generally be achieved.

Transvaginal ultrasounds can check for the shape, position, and size of the ovaries and uterus, thickness and length of the cervix and blood flow through the organs in the pelvis and the shape of the bladder and any changes.

This scan can also help to diagnose benign growths, such as fibroids, cysts, and masses, pelvic inflammatory disease, endometriosis, postmenopausal bleeding.