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Background
Background
Breast cancer remains one of the most prevalent and deadly cancers in the United States, accounting for nearly one-third of all cancer diagnoses and over 40,000 deaths annually. Despite ongoing research, many lifestyle-related risk factors remain inconclusive, with emerging evidence suggesting that genetic predisposition and environmental exposures (particularly to carcinogens and endocrine disruptors) play a more substantial role in disease onset. Around 80% of all breast cancer cases are invasive ductal carcinomas, which begin in the epithelial cells lining the milk ducts. These ducts are part of an open system through which fluids can travel, raising concerns that external contaminants may enter the breast tissue via reverse flow under pressure differentials.
This project addresses that concern by developing a biocompatible, durable, and discreet nipple-sealing device designed to prevent unwanted fluid infiltration into the ducts, especially in high-risk environments where exposure to harmful substances, such as those found in personal care products or contaminated water, may be elevated. A clinical trial is also being launched to evaluate the device’s safety, comfort, and effectiveness in reducing ductal inflammation, a known contributor to cancer development. By targeting environmental exposure and early inflammatory processes, this work introduces a novel, non-invasive strategy for proactive breast cancer prevention.
Problem Statement
Problem Statement
Need: Since inflammation is tied to the development of breast cancer, the use of a water tight device to cover the nipple could prevent inflammatory substances, such as soap, from entering open ducts, reducing (and potentially eliminating) inflammation in the milk ducts.
This project focuses on the development of a skin-safe, watertight device designed to seal the nipple and prevent fluid infiltration into the breast ducts. Key design priorities include ensuring a reliable waterproof barrier, using hypoallergenic materials suitable for diverse skin types, maximizing comfort and discretion to encourage regular use, and maintaining durability under environmental stress such as water pressure.
To evaluate the device’s impact, a clinical trial is being developed to test its effectiveness in reducing inflammation in the breast ducts, a potential risk factor for cancer. The trial will also assess broader outcomes including user comfort, cost-effectiveness, and the device's environmental footprint, helping determine its feasibility for long-term, real-world use.
Problem Statement: Currently breast cancer prevention lacks adequate mitigation devices or procedures without being significantly invasive and carrying significant risks; it is predominantly relying on early detection methods.
Overview of Device
Overview of Device
Silicone Device (left) with Diamora
Dressing Adhesive Applied Over
This design iteration (our current design) utilized all of the previous design iterations to inform the choices made in this design. A petal shape was used in order to account for the curvature of the breast, as the team decided that a petal shape could adapt to different breast shapes (compared to a circular shape). Additionally, the device has curvature on the back in order to accommodate the nipple, and to prevent compression of the nipple. The adhesive chosen to adhere the device to the breast is the Diamora dressing adhesive, as the Dexcom adhesive could not provide total coverage of the petal shaped device, which was discovered in early testing stages. The Dexcom adhesive had small gaps when paired with the petal-shaped device, causing the team to pivot to the Diamora dressing adhesive, which provided complete coverage and adhesive to the device.
Overview of Clinical Trial
Overview of Clinical Trial
To bring the device to clinical use, the first step involves submitting detailed protocol documents to both the FDA and Institutional Review Board (IRB) to determine risk classification. Based on this classification, the appropriate regulatory pathway, 510(k), PMA, or De Novo, will be pursued. Following regulatory review, ISO biocompatibility testing for external intact surfaces will confirm the safety of materials. An Investigational Device Exemption (IDE) will then be secured to begin clinical trials.
The trial will proceed through four phases: Phase 1 will assess device comfort and usability in a limited population over six months; Phase 2 will evaluate effectiveness by testing for inflammation markers over one year; Phase 3 will expand testing to a larger population over two years; and Phase 4 will involve post-market surveillance to monitor long-term outcomes and safety. For this clinical trial, the project included drafting informed consent paperwork, a harm response plan, and procedures to prevent bias and ensure data integrity. As well, exclusion criteria has been considered to apply to specific populations, including individuals who are breastfeeding or have had surgeries, implants, or piercings.
Global Impact
Global Impact
This project addresses a critical gap in breast cancer prevention by developing a non-invasive, accessible device designed to reduce exposure to potential environmental carcinogens through the breast ducts. By targeting ductal inflammation, an early contributor to cancer development, the device offers a proactive approach to reducing breast cancer risk, particularly for high-risk individuals and underserved populations with limited access to preventative care.
If proven effective, this innovation could be implemented globally as a low-cost, user-friendly intervention to complement existing screening and prevention strategies. Its scalable design and focus on comfort and biocompatibility make it suitable for widespread use across diverse healthcare systems, offering a meaningful step forward in global women’s health and cancer prevention.
Page done by: Elizaveata Borroum
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