R43HD113449

Intravaginal device for the treatment of pelvic pain and dyspareunia in female cancer survivors - Summary:

More than half of female cancer survivors will experience chronic pelvic pain and dyspareunia (painful intercourse) due to their cancer treatments. As the number of cancer survivors continues to grow, so too will the number of women in need of effective treatments for this life-altering condition.

Pelvic floor physical therapists currently use several different devices during in-clinic and at-home therapy (vaginal dilators, pelvic wands, vibration devices) but these devices are unregulated, lack appropriate ergonomics, and do not consider comprehensive functionality, patient-specific needs, and the physical challenges common to cancer survivors.

Survivors seek an effective multimodal solution that also provides them with the knowledge, skills, and confidence to advocate for their own sexual health.

Cervu, Inc. is developing a patent-pending intravaginal device for the highly individualized needs of female cancer survivors that is uniquely designed for dilation, vibration, myofascial release, and trigger point massage therapies.

To date, prototype form factor designs have been 3D printed and mailed to patients and providers through multiple rounds of user testing, resulting in down-selection to a candidate design for further development.

The objective of this Phase 1 SBIR proposal is to confirm feasibility of function within the confines of the candidate form factor, and to acquire further user feedback prior to design freeze for first-in-human studies.

Aim 1. Develop and validate a functional alpha prototype. We will collaborate with design and manufacturing partners to (1) resolve remaining design questions such as selecting appropriate materials, specifying eccentric rotating mass vibration motor and electrical components, and finalizing the handle-dilator attachment mechanism; (2) manufacture a minimum viable product; and (3) validate function agreement with specifications through extensive bench testing.

Goals: (1) Device meets form and function specifications including handle and dilator size and curvature tolerance, handle pitch and roll range of motion, vibration frequency, charging speed, visual indicators, dilator durometer, handle attachment/detachment force, weight distribution, and quality consistency; (2) Production of 5 alpha prototypes that meet or exceed specifications.

Aim 2. Demonstrate ability of alpha prototype to meet user needs. We will validate design form agreement through formative user testing in 10 total subjects including pelvic floor physical therapists and female cancer survivors with dyspareunia. Subjects will receive prototypes and will be interviewed on the specific device features as well as anticipated ability to perform therapy.

Goal: More than 80% of users rate each feature = 3 on a 5-point Likert scale.

The proposed work is expected to demonstrate that a functional device can be implemented within a form factor that ensures user acceptance.

Impact: This device has the potential to transform dyspareunia treatment, one of the most common conditions affecting quality of life in female cancer survivors.

Cervu

TO CONDUCT AND SUPPORT LABORATORY RESEARCH, CLINICAL TRIALS, AND STUDIES WITH PEOPLE THAT EXPLORE HEALTH PROCESSES. NICHD RESEARCHERS EXAMINE GROWTH AND DEVELOPMENT, BIOLOGIC AND REPRODUCTIVE FUNCTIONS, BEHAVIOR PATTERNS, AND POPULATION DYNAMICS TO PROTECT AND MAINTAIN THE HEALTH OF ALL PEOPLE. TO EXAMINE THE IMPACT OF DISABILITIES, DISEASES, AND DEFECTS ON THE LIVES OF INDIVIDUALS. WITH THIS INFORMATION, THE NICHD HOPES TO RESTORE, INCREASE, AND MAXIMIZE THE CAPABILITIES OF PEOPLE AFFECTED BY DISEASE AND INJURY. TO SPONSOR TRAINING PROGRAMS FOR SCIENTISTS, DOCTORS, AND RESEARCHERS TO ENSURE THAT NICHD RESEARCH CAN CONTINUE. BY TRAINING THESE PROFESSIONALS IN THE LATEST RESEARCH METHODS AND TECHNOLOGIES, THE NICHD WILL BE ABLE TO CONDUCT ITS RESEARCH AND MAKE HEALTH RESEARCH PROGRESS UNTIL ALL CHILDREN, ADULTS, FAMILIES, AND POPULATIONS ENJOY GOOD HEALTH. THE MISSION OF THE NICHD IS TO ENSURE THAT EVERY PERSON IS BORN HEALTHY AND WANTED, THAT WOMEN SUFFER NO HARMFUL EFFECTS FROM REPRODUCTIVE PROCESSES, AND THAT ALL CHILDREN HAVE THE CHANCE TO ACHIEVE THEIR FULL POTENTIAL FOR HEALTHY AND PRODUCTIVE LIVES, FREE FROM DISEASE OR DISABILITY, AND TO ENSURE THE HEALTH, PRODUCTIVITY, INDEPENDENCE, AND WELL-BEING OF ALL PEOPLE THROUGH OPTIMAL REHABILITATION.

93.865 - Child Health and Human Development Extramural Research

National Institute of Child Health and Human Development (NICHD) [HHS - NIH]

North Carolina United States

State-Wide

PHS 2022-2 Omnibus Solicitation of the NIH, CDC and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Not Allowed) (PA-22-176)

Amendment Since initial award the End Date has been extended from 08/31/24 to 08/31/25 and the total obligations have decreased from $391,500 to $391,359.