SBIR-STTR Award

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.

Thesaurus Terms:
biomedical equipment development, catheterization, method development, ovariectomy, surgery material /equipment blood coagulation, body cavity, cervix, fallopian tube, female reproductive system disorder diagnosis, heat, mucosa female, female reproductive system surgery, laboratory rabbit

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. , ,

Public Health Relevance:
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.

Thesaurus Terms:
Acute;Adverse Experience;Adverse Event;After Care;After-Treatment;Aftercare;American;Animal Model;Animal Models And Related Studies;Animals;Assay;Bioassay;Biologic Assays;Biological Assay;Body Tissues;Breeding;Cannulations;Capital;Catheters;Chemicals;Chronic;Clinical;Clinical Evaluation;Clinical Research;Clinical Study;Clinical Testing;Consent;Data;Data Set;Dataset;Devices;Dose;Enrollment;Ethics Committees, Research;Evaluation;Fallopian Tubes;Female Sterilization;Funding;Future;Goals;Hand;Harvest;Healed;Histopathology;Home;Home Environment;Human;Human, General;Hysterectomy;Hysterosalpingography;Hysteroscopy;Iacuc;Irbs;Implant;Institution;Institutional Animal Care And Use Committee;Institutional Review Boards;Left;Lesion;Light;Mammalian Oviducts;Mammals, Rabbits;Man (Taxonomy);Man, Modern;Method Loinc Axis 6;Methodology;Methods;Monitor;Operation;Operative Procedures;Operative Surgical Procedures;Organ;Oryctolagus Cuniculus;Outcome;Partner In Relationship;Pathologist;Patients;Perforation;Performance;Phase;Photoradiation;Physicians;Pilot Projects;Preparation;Probability;Problem Solving;Procedures;Process;Programs (Pt);Programs [publication Type];Quality Control;Rabbit, Domestic;Rabbits;Recovery;Regulation;Research Ethics Committees;Sched;Safety;Salpinx;Schedule;Seasons;Secure;Series;Serous Membrane;Simulate;Sterilization;Surgical;Surgical Interventions;Surgical Procedure;System;System, Loinc Axis 4;Technology;Temperature;Testing;Therapeutic;Time;Tissues;Treatment Efficacy;Treatment Outcome;Tubal Ligation;Tubal Occlusion;Tubal Sterilization;Tube;Uncertainty;Uterine Endoscopy;Uterine Tubes;Uteroscopy;Validation;Woman;Work;Analytical Method;Animal Tissue;Base;Birth Control;Clinical Efficacy;Clinical Practice;Clinical Relevance;Clinical Test;Clinically Relevant;Cost Effective;Design;Designing;Dosimetry;Doubt;Efficacy Trial;Enroll;Experience;Experiment;Experimental Research;Experimental Study;Fallopian Tube Ligation;Healing;Hysterosalpingogram;In Vivo;Interest;Mate;Model Organism;New Technology;Novel;Oviduct;Pilot Study;Pre-Clinical;Preclinical;Preclinical Safety;Programs;Prototype;Public Health Relevance;Reproductive;Research Clinical Testing;Research Study;Response;Sensor;Serosa;Surgery;Therapeutic Efficacy;Therapeutically Effective;Treatment Response