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Improving Repair of Female Congenital and Reproductive Anomalies

改善女性先天性和生殖异常的修复

基本信息

批准号：
9466595
负责人：
Ashok Gowda
金额：
$ 22.5万
依托单位：
BIOTEX, INC.
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-20 至 2018-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9466595
关键词：
Address Adolescent Adult Aftercare Agreement Anatomic Models Anatomy Animal Model Animals Biomechanics Cancer Patient Childhood Cicatrix Clinical Clinical Research Coupling Devices Economic Inflation Engineering Family suidae Female Female Adolescents Fingers Geometry Goals Gynecologic Gynecology Health Care Costs Hour Image Analysis In Situ Injury Left Legal patent Length Magnetism Malignant Female Reproductive System Neoplasm Medical Device Medicine Morbidity - disease rate Movement Necrosis North America Numeric Rating Scale Operative Surgical Procedures Outcome Parents Patients Pediatric Hospitals Pelvis Performance Phase Physicians Population Positioning Attribute Postoperative Complications Postoperative Period Preparation Problem Solving Process Property Radiation Radiation therapy Recovery Retrieval Small Business Innovation Research Grant Stenosis Stents Sterility Surgical complication Testing Texas Time Tissues Traction United States Vagina Woman base cancer therapy college design girls healing improved in vivo irritation novel operation pressure prevent prototype reconstruction repaired reproductive restenosis time use young woman

项目摘要

Project Summary The overall goal of this SBIR proposal is to develop a novel vaginal stent for use in pediatric and adult populations. There are many girls and women born with congenital gynecologic abnormalities requiring surgical reconstruction of their vaginal cavities. There are also women who have very shortened or scarred vaginas after pelvic surgery or radiation treatment for cancer. Vaginal stents can be used after neo-vagina creation to prevent scarring and re-stenosis. There are no currently available vaginal stents that meet the anatomic needs of pediatric and adolescent girls or women who are post treatment for gynecologic cancers. As such, there is a high rate of post-surgical complications such as vaginal tissue scaring and vaginal stenosis. We propose to create new vaginal stents with improved fit, ease of use, unique deployment and retrieval mechanisms, and enhanced comfort for a pediatric population and for those women with shortened vaginas. BioTex has entered into an option agreement with collaborating physicians at Texas Children’s Hospital (Baylor College of Medicine) to create the newly designed stent based on pending patents filed by our clinical collaborators. The objectives of our Phase I proposal is to build fully functional prototypes, conduct benchtop testing, and perform in vivo studies in porcine vaginal tracts to demonstrate performance of the stents. We believe this new vaginal stent will reduce post-surgical morbidity, early discontinuation of stent use postoperatively, reduce health care costs, and improve clinical outcomes for girls and women across North America.

项目总结