Breast cancer is one of the most common and costly health conditions affecting individuals today:
1 in 3 cancer diagnoses is breast cancer.
Approximately 315,000 new cases are diagnosed each year in the U.S.
Over 40,000 deaths occur annually due to breast cancer.
The condition accounts for over $25 billion in medical costs per year.
About 80% of breast cancer cases are ductal carcinomas which are cancers that start in the cells lining the milk ducts. This highlights a vulnerable entry point for harmful substances, making ductal protection a key area of prevention focus.
Participants are chosen across a range of ages and medical backgrounds to reflect real-world diversity and assess device performance across different populations.
Age Range: Primarily adults aged 20 to 60 years
Health Backgrounds: Includes individuals with and without a family history of breast cancer, as well as those with genetic predispositions
Physical Requirements: Natural breast anatomy is required for proper device application and assessment
Each trial phase includes a broader and more representative population, starting with healthy individuals and gradually including those with relevant medical histories.
Who Is Excluded?:
To maintain data quality and reduce confounding variables, the following groups are excluded from the clinical trial:
Breastfeeding individuals – to avoid natural inflammation and milk duct activity interfering with results
Patients with breast implants or piercings – which may prevent proper device adhesion or skew comfort/safety results
Those who have undergone breast surgeries or mastectomies – as altered anatomy can affect both device placement and physiological readings.
Individuals unable to consistently follow device usage protocols or attend follow-up visits
These exclusions are based on ensuring both participant safety and scientific accuracy.
Why These Groups Matter:
Choosing the right participants helps the study:
Reduce risk of inflammation unrelated to the device
Ensure consistent device placement and performance
Gather clear data on how well the device works in preventing early signs of breast cancer
As the study progresses, inclusion expands to reflect a wider patient population while still adhering to safety standards and ethical guidelines.
Page done by: Grace Bassey