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：
10023187
负责人：
Ashok Gowda
金额：
$ 81.4万
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 2022-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10023187
关键词：
Address Adolescent Adult Aftercare Age Anatomic Models Anatomy Animal Model Animals Caliber Cancer Patient Childhood Cicatrix Clinical Clinical Trials Custom Databases Development Devices Engineering Family suidae Female Female Adolescents Goals Gynecologic Health Care Costs Institution Length Maintenance Malignant Female Reproductive System Neoplasm Medical Medical center Medicine Morbidity - disease rate North America Operative Surgical Procedures Outcome Patients Pediatric Hospitals Pelvis Performance Phase Physicians Population Postoperative Period Production Protocols documentation Radiation Radiation therapy Reconstructive Surgical Procedures Retrieval Sampling Small Business Innovation Research Grant Stenosis Stents Sterilization Surgical complication System Testing Texas Tissues Update Vagina Validation Woman Work adolescent patient base biomaterial compatibility cancer therapy cohort college commercialization comorbidity compliance behavior design ergonomics follow-up girls healthy volunteer improved in vivo instrument novel performance tests pre-clinical prevent product development prototype reconstruction repaired reproductive restenosis success surgery outcome tool usability verification and validation volunteer 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 completed a SBIR Phase I project where we created novel stents and deployment mechanisms, completed benchtop performance testing, and evaluated multiple design configurations during in vivo animal studies with promising results. The objectives of our Phase II proposal is to build on this work by creating updated custom prototypes based on prior pre-clinical work and physician input, test designs in normal volunteer subjects, lock down a final design and complete required validations for FDA 510(k) filing, and test the stents in the intended population of adolescents undergoing vaginal reconstructive surgery, and women after radiation treatment for gynecologic cancers. 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.

项目摘要该SBIR提案的总体目标是开发一种新型的阴道支架，用于小儿和成人人群。有许多女孩和妇女出生的先天性妇科异常需要其阴道腔的手术重建。还有一些妇女缩短或疤痕骨盆手术或癌症辐射治疗后的阴道。在新维吉纳（Neo-Vagina）之后可以使用阴道支架创建以防止疤痕和重新发生。当前没有可用的阴道支架可以符合儿科和青少年女孩或妇科癌症治疗后的儿科和青少年的解剖需求。因此，术后并发症的率很高，例如阴道组织恐怖和阴道狭窄。我们建议以提高适合度，易用性，独特的部署和检索机制，以及针对小儿人群以及缩短的妇女的舒适感阴道。 Biotex已经完成了一个SBIR I期项目，我们在其中创建了新颖的支架和部署机制，完成了台式性能测试，并评估了体内动物期间多种设计配置具有令人鼓舞的结果的研究。我们第二阶段提案的目标是通过创建这项工作来建立这项工作根据先前的临床前工作和医师输入，更新的自定义原型，正常测试设计志愿者主题，锁定最终设计，并为FDA 510（k）备案提供完整的验证，并进行测试预期人群接受阴道重建手术和妇女的支架辐射治疗妇科癌。我们认为，这种新的阴道支架会减少手术后的术后发病率，术后暂时停用使用，降低医疗保健成本并改善临床北美女孩和妇女的成果。