A simple device for office evaluation of tubal patency during the workup for infertility.

PROJECT SUMMARY OryGyn Medical Devices, LLC is developing a novel and highly innovative Tubal Selective Delivery System (TSDS) designed to safely and selectively administer fluids, foams, or gels to the fallopian tubes through a nonsurgical transcervical approach. The basic work-up of infertility includes evaluation of whether the tubes are open to passage of eggs and sperm (fallopian tube patency) using a hysterosalpingogram, a radiologic study that requires referral to a specialist and exposure to ionizing radiation. The TSDS would provide clinicians with a simple and convenient office-based option for evaluation of tubal occlusion without referral to specialists. The worldwide prevalence of infertility, defined as failure to conceive after more than 12 months of unprotected intercourse, is approximately 8%–12% and decreased ability to conceive - subfertility - affects an additional 15% of couples. The TSDS would increase convenience for patients and decrease costs associated with evaluation of this problem. In this Phase I proposal, we propose the following objectives: Aim 1: Compare characteristics of internal and external frame designs to identify and manufacture a second generation FertChx TSDS; Aim 2: Demonstrate the performance characteristics of FertChx using a simulated uterine model to establish benchmarks for a clinical testing. This Phase I project will characterize the performance of a lead device and provide documentation of the good manufacturing practices (GMP) required for production of devices for a clinical trial. Successful completion of Phase I will support submission of a Phase II proposal to complete a clinical trial evaluating safety and efficacy of the device for verification of tubal patency and necessary components for regulatory review. Together, the Phase I and II programs will support our business objective of 510(K) approval of the lead TSDS device for use as an office-based device for tubal patency evaluation.