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.

项目概要该 SBIR 提案的总体目标是开发一种用于儿科和成人的新型阴道支架人口。许多女孩和妇女出生时就患有先天性妇科异常，需要接受治疗手术重建她们的阴道腔。也有一些女性的皮肤很短或有疤痕盆腔手术或癌症放射治疗后的阴道。新阴道术后可使用阴道支架创建以防止疤痕和再狭窄。目前尚无符合要求的阴道支架儿科和青春期女孩或妇科癌症治疗后妇女的解剖学需求。因此，术后并发症的发生率很高，例如阴道组织疤痕和阴道异物狭窄。我们建议创建新的阴道支架，具有改进的贴合性、易用性、独特的部署和检索机制，并提高儿科人群和缩短的妇女的舒适度阴道。 Biotex 已完成 SBIR 第一阶段项目，我们在该项目中创建了新颖的支架和部署机制，完成了台式性能测试，并在体内动物期间评估了多种设计配置研究取得了有希望的结果。我们第二阶段提案的目标是通过创建根据先前的临床前工作和医生的输入更新定制原型，正常测试设计志愿者受试者，锁定最终设计并完成 FDA 510(k) 备案所需的验证，并进行测试支架用于接受阴道重建手术的青少年和女性的目标人群妇科癌症放射治疗后。我们相信这种新的阴道支架将减少术后并发症发病率、术后早期停止使用支架、降低医疗费用并改善临床北美地区女孩和妇女的成果。