Development and testing of the Novocuff device to prevent infant morbidities and mortalities caused by preterm birth.

开发和测试 Novocuff 装置，以预防早产引起的婴儿发病和死亡。

• 批准号: 10761418
• 负责人: Donald Lee
• 金额: $ 29.56万
• 依托单位: NOVOCUFF INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-10 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10761418
• 关键词: 37 weeks gestation; Accounting; Address; Age; American College of Obstetricians and Gynecologists; Anatomy; Applications Grants; Atopobium vaginae; Birth History; Black race; Businesses; California; Cause of Death; Cervical; Cervical Cerclage; Cervix Uteri; Clinical; Clinical Treatment; Clinical Trials; Development; Devices; Engineering; Environment; Evidence based treatment; FDA approved; Fetal Viability; Fetus; Future; Gestational Age; Grant; Health Care Costs; Hospital Costs; Human Resources; Infant; Infant Mortality; Institution; Intramuscular; Length; Low income; Maternal Health; Mechanics; Medical Device; Modality; Modeling; Newborn Infant; Nulliparity; Operative Surgical Procedures; Patients; Pessaries; Phase; Physicians; Population; Population Group; Positioning Attribute; Preclinical Testing; Pregnancy; Pregnancy loss; Premature Birth; Progesterone; Prolonged Pregnancy; Provider; Randomized Controlled Clinical Trials; Readiness; Recommendation; Recording of previous events; Risk; Risk Factors; Risk Reduction; Second Pregnancy Trimester; Small Business Innovation Research Grant; Specialist; Surgical sutures; Testing; Tissues; Transvaginal Ultrasound; Trauma; Twin Multiple Birth; Uncertainty; United States; Vagina; biomaterial compatibility; clinic ready; clinical practice; clinical trial readiness; commercialization; cost; design; design verification; education research; efficacy evaluation; high risk population; improved; infant death; infant morbidity; infant morbidity/mortality; maternal morbidity; minimally invasive; pathogen; pharmacologic; phase 1 study; pre-clinical; pregnant; prevent; skills training; social factors; vaginal microbiota; 37 weeks gestation; Accounting; Address; Age; American College of Obstetricians and Gynecologists; Anatomy; Applications Grants; Atopobium vaginae; Birth History; Black race; Businesses; California; Cause of Death; Cervical; Cervical Cerclage; Cervix Uteri; Clinical; Clinical Treatment; Clinical Trials; Development; Devices; Engineering; Environment; Evidence based treatment; FDA approved; Fetal Viability; Fetus; Future; Gestational Age; Grant; Health Care Costs; Hospital Costs; Human Resources; Infant; Infant Mortality; Institution; Intramuscular; Length; Low income; Maternal Health; Mechanics; Medical Device; Modality; Modeling; Newborn Infant; Nulliparity; Operative Surgical Procedures; Patients; Pessaries; Phase; Physicians; Population; Population Group; Positioning Attribute; Preclinical Testing; Pregnancy; Pregnancy loss; Premature Birth; Progesterone; Prolonged Pregnancy; Provider; Randomized Controlled Clinical Trials; Readiness; Recommendation; Recording of previous events; Risk; Risk Factors; Risk Reduction; Second Pregnancy Trimester; Small Business Innovation Research Grant; Specialist; Surgical sutures; Testing; Tissues; Transvaginal Ultrasound; Trauma; Twin Multiple Birth; Uncertainty; United States; Vagina; biomaterial compatibility; clinic ready; clinical practice; clinical trial readiness; commercialization; cost; design; design verification; education research; efficacy evaluation; high risk population; improved; infant death; infant morbidity; infant morbidity/mortality; maternal morbidity; minimally invasive; pathogen; pharmacologic; phase 1 study; pre-clinical; pregnant; prevent; skills training; social factors; vaginal microbiota

PROJECT SUMMARY/ABSTRACT Preterm birth (PTB), delivery < 37 weeks gestational age (GA), is the leading cause of death for infants under the age of one. In addition, PTB is associated with costs of $26 billion dollars per year in the United States (US) - accounting for half of all infant-related hospitalization costs. One of the greatest risk factors for spontaneous PTB, which comprises 70% of all PTBs, is a short cervix (i.e. shortened cervical length on transvaginal ultrasound). There is currently no FDA approved device that addresses the 360,000 annual spontaneous PTBs in the US; there are also no consistently proven pharmacologic therapies. The only effective mechanical treatment option available is a cerclage, a surgical procedure involving suturing the cervix closed. There are however, numerous limitations to cerclages: 1) as a surgical procedure it requires access to an operative room, personnel, and its associated costs, 2) it is only be performed up to fetal viability (22-24 weeks GA), 3) it requires a highly skilled trained provider, usually a specialist 4) it is not recommended for patients with multiple gestations 5) it is indicated (and proven beneficial) only in patients with a shortened cervical length and prior PTB/2nd trimester pregnancy loss and 6) while it may be performed in other populations emergently for cervical dilation as a rescue cerclage, has shown no consistent benefit. Novocuff Inc., a California-based small business, is developing an easy to use, minimally invasive, non-surgical device intended to reduce the risk of spontaneous PTB. The Novocuff device is designed to support the cervix, assist in maintaining cervical length, and adjust the angle of the cervix to decrease the forces that lead to cervical shortening. Preliminary benchtop studies have demonstrated Novocuff’s ability to apply circumferential compression around a cervix model without causing trauma to the cervical tissue. The risk profile of the Novocuff device is considerably lower than the cerclage since it is non-surgical, not embedded in the cervix, and can be placed/adjusted in an office setting. The decreased risk profile would not only allow it to be used in lieu of a cerclage, but also for those in whom a cerclage is not indicated (i.e. twins, nulliparas), and >24 weeks GA, increasing treatment options for physicians and patients. Novocuff has the support of key opinion leaders at respected educational research institutions. These physicians have provided valuable clinical input regarding the design and application of the Novocuff device and will assist in verifying the design during any future benchtop studies. The next step in design verification and the key focus of the proposed Phase I project, is to determine the feasibility and clinical readiness of the Novocuff device. Our specific aims are to 1) test that the Novocuff device can apply comparable forces to the cervix as a surgical cerclage, 2) test Novocuff biocompatibility and bioburden and 3) test that the Novocuff device passes all functional requirements. At the end of Phase I, Novocuff will have completed all the necessary preclinical testing to demonstrate mechanical readiness for a clinical trial. Phase II efforts will focus on supporting an FDA submission. The broad, long-term objective of this Phase I grant application is to improve clinical treatment options that bridge the gap between potentially viable and healthy newborns, decrease the risk of PTB, and to reduce infant mortality, with its associated effects on maternal health.

项目摘要/摘要 早产（PTB），分娩<37周胎龄（GA）是婴儿下的主要死亡原因 一个年龄。此外，PTB与美国每年260亿美元的成本有关（美国） - 会计 在所有与婴儿有关的住院费用中的一半。赞助PTB的最大风险因素之一，其中包括 所有PTB的70％是一个短子宫颈（即，经阴道超声上的宫颈长度缩短）。 目前尚无FDA批准的设备来解决美国360,000个年度赞助的PTB；那里 也不是一贯证明的药理疗法。可用的唯一有效的机械治疗选择是 CERCLAGE，涉及子宫颈闭合的手术程序。但是，有许多限制 CERCLAGES：1）作为手术程序，需要进入手术室，人员及其相关费用，2） 仅对胎儿生存能力（22-24周GA）进行，3）需要一个高技能的训练有素的提供者，通常是一个 专家4）不建议使用多个妊娠的患者5）仅在 颈椎长度缩短和先前的PTB/第二期妊娠损失的患者，6）虽然可以在 其他人群作为宫颈词典作为救援环境的紧急情况，没有显示出一致的好处。 位于加利福尼亚的小型企业Novocuff Inc.正在开发易于使用的，微创，非外科 设备旨在降低赞助PTB的风险。 Novocuff设备旨在支撑子宫颈，协助 保持颈长度，并调节子宫颈的角度，以减少导致宫颈缩短的力。 初步的台式研究表明，诺瓦夫有能力在围绕一个 子宫颈模型，而不会引起宫颈组织创伤。 Novocuff设备的风险概况较低 由于它是非手术的，而不是嵌入子宫颈，并且可以将其放置/调整在办公室环境中，因此它比环境不相比。 降低的风险状况不仅可以用它代替Cerclage，还可以使用它 未指示（即双胞胎，零帕拉斯）和> 24周的GA，这增加了医生和患者的治疗选择。 Novocuff得到了受人尊敬的教育研究机构的关键意见领导者的支持。这些医生 已经提供了有关Novocuff设备的设计和应用的宝贵临床输入，并将有助于 在任何将来的台式研究中验证设计。设计验证的下一步和关键重点 提出的第一阶段项目是确定Novocuff设备的可行性和临床准备性。我们的具体目标 要1）测试Novocuff设备可以将可比较的力应用于子宫颈，以作为手术环境，2）测试Novocuff 生物相容性和生物负担以及3）测试NovoCuff设备通过所有功能要求。在 第一阶段，Novocuff将完成所有必要的临床前测试，以证明机械准备就绪 临床试验。第二阶段的努力将集中于支持FDA提交。这一阶段的广泛，长期目标 赠款的应用是改善临床治疗方案，弥合潜在可行和健康之间的差距 新生儿，降低了PTB的风险，并降低婴儿死亡率，并对孕产妇健康的影响相关。