A safe and reliable procedure to perform transcervical sterilization could replace laparoscopic tubal ligation - the most popular permanent birth control method. Over 700,000 American women are expected to receive the tubal surgery this year. The transcervical approach offers a significant improvement because it shortens recovery for the patient and increases practice efficiency for the physician by making an office-based sterilization procedure feasible. Novomedics'transcervical procedure takes advantage of the body's natural healing effects to scare off the fallopian tube. Our approach uses a proprietary thermal catheter to treat a sufficient amount of the tubal lumen. Pilot in vivo and survival data with an early prototype have demonstrated effective and reliable tubal occlusion in two weeks without leaving any foreign materials in the fallopian tube. In addition, pilot human safety data has also been obtained. In the proposed Phase II program, we will incorporate novel safety features demonstrated in Phase I and strengthen the design and quality of the NovoSeal system to be ready for large scale clinical evaluation in Phase III. The end result of this effort will be a new technology for safe and effective transcervical female sterilization:
Specific Aim 1. Evaluation of NovoSeal catheter system and treatment method in freshly extirpated human and animal reproductive tissue in preparation for quantitative in vivo preclinical and clinical studies.
Specific Aim 2. In vivo characterization of the NovoSeal catheter and treatment method in an established animal model.
Specific Aim 3. In vivo characterization of the NovoSeal catheter and treatment method in human reproductive tissue during peri-hysterectomy surgery.
Specific Aim 4. A pilot study for in vivo characterization of the NovoSeal catheter and treatment method in human pre-hysterectomy patients.
Project Narrative The clinical practice of transcervical sterilization is growing and Novomedics'proposed technology has numerous advantages over current product offerings. Our technology solves problems with previous thermal approaches and will offer physicians a simple, cost effective, and efficient method for achieving permanent sterilization without the requirement of a surgical procedure or the use of implants. The commercial potential for such a technology is without doubt very large, especially in light of the increased patient benefits of avoiding invasive surgery as well as the time and convenience to physicians who use the technology for an office-based sterilization procedure.