Novel Thermal Transcervical Sterization Device

DESCRIPTION (provided by applicant): 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 scar 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 tubal occlusion in two weeks without leaving any foreign materials in the fallopian tube. Novomedics' goal is to develop both an effective and safe catheter based device for the sterilization procedure. In the proposed Phase I project, we plan to investigate the feasibility of improving the safety features of our device: Aim 1. Develop safeguards that alert tubal perforation: novel methods to detect accidental perforation from tubal cannulation will be evaluated. If feasible, such an approach may protect the patient by preventing the physician from commencing treatment if the tube was perforated. Aim 2. Determine effectiveness of automated heat-controller to regulate coagulation ex vivo: an intelligent thermal feedback controller will be evaluated to achieve consistent thermal treatments using the rabbit fallopian tube model. Such experiments will help Novomedics to select appropriate treatment parameters to be verified in a survival study (Aim 3). Aim 3. Determine system parameters to achieve a safe and effective treatment margin in vivo: Assess treatment effects based on histologic assessments of the tube and surrounding tissues to ensure heat containment. Breeding test performed on rabbits post Novomedics treatment will provide a well defined end point to evaluate efficacy.