Device for Surgical Adhesion Prevention

预防手术粘连装置

• 批准号: 7909040
• 负责人: Rekha Bansal
• 金额: $ 26.6万
• 依托单位: NOVELMED THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-13 至 2013-05-12
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7909040
• 关键词: Abdomen; Address; Adhesions; Adhesives; Adverse effects; Awareness; Back; Biocompatible; Blood Platelets; Cannulas; Carbohydrates; Cardiac Surgery procedures; Cell Proliferation; Cellular Assay; Clinical; Clinical Trials; Complication; Cytolysis; Data; Development; Device Approval; Devices; Diagnostic Procedure; Disease; Doctor of Philosophy; Drug Kinetics; Dyes; Europe; FDA approved; Feasibility Studies; Fibrosis; Fluoroscopy; Flushing; Gel; Goals; Growth; Gynecologic; Gynecologic Surgical Procedures; Healed; Health Care Costs; Hemostatic function; Hospitals; Image; Imaging Techniques; Implant; In Vitro; Infertility; Intellectual Property; Intestinal Obstruction; Laminectomy; Laparoscopic Surgical Procedures; Legal patent; Link; Mammalian Oviducts; Marketing; Measures; Methods; Modeling; Molecular Structure; Nerve; Neuraxis; Operative Surgical Procedures; Oryctolagus cuniculus; Pain; Patients; Pelvis; Peritoneum; Phase; Physicians; Pleura; Postoperative Period; Pregnancy Rate; Prevention; Procedures; Property; Rattus; Reporting; Risk; Role; Safety; Sales; Site; Small Intestines; Spinal; Structure; Surface; Surgeon; Surgical complication; Surveys; Symptoms; Synovial Membrane; Tendon structure; Testing; Tissues; Toxic effect; Treatment Efficacy; United States; Vagina; Vertebral column; Work; Wound Healing; analog; base; chronic pain; clinically relevant; cost; disability; healing; improved; meetings; new technology; novel; operation; pericardial sac; preclinical study; prevent; public health relevance

DESCRIPTION (provided by applicant): Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for the complications from surgical adhesions. After surgery, fibrous adhesions form in the peritoneum, central nervous system, pericardium, pleura and synovium. Fibrous adhesion that develop after surgery cause complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. Despite the need for anti-adhesive treatments, there are currently no FDA approved prevention devices that effectively prevent surgical adhesions following spinal and laparoscopic surgery. One obstacle to gaining FDA approval for therapies targeting prevention of adhesions has been the lack of good clinical endpoint measures to assess treatment efficacy. NovelMed has developed a novel synthetic carbohydrate, NM2040, based on a previous synthetic anionic carbohydrate, ADCON, which despite successfully inhibiting adhesions, and had reports of significant side-effects. NovelMed recently discovered that ADCON is toxic to platelets. Given the critical role of platelets in hemostasis and wound healing, ADCON's side-effects could be linked to platelet toxicity. NM2040 was developed to overcome the toxic effects of ADCON on platelets. Preliminary findings indicate that this biocompatible conjugate can effectively inhibit surgical adhesions by preventing invasion and proliferation of cells associated with fibrosis development into the surgical site without platelet toxicity. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries. PUBLIC HEALTH RELEVANCE: Postoperative adhesion formation is the single greatest complication of surgery. Twenty seven million surgical procedures are performed annually in the U.S. where the patient is at risk for complications that markedly increase healthcare costs due to increased rates of re-operation, postoperative bowel obstruction, infertility, and chronic pain. The objectives of this application are 1) to test the feasibility of using NM2040 as a treatment to prevent surgical adhesions using a validated lumbar spine laminectomy model; 2) to develop a surgical adhesion model for gynecological adhesions for which good clinical endpoint measures are available; and to determine efficacy of NM2040 to prevent fallopian tube adhesions. Our ultimate goal is to develop an effective FDA approved anti-adhesion device for use in back and abdominal surgeries.

描述(申请人提供)：术后粘连形成是手术最大的并发症。在美国，每年有2700万例外科手术，患者面临手术粘连并发症的风险。手术后，腹膜、中枢神经系统、心包、胸膜和滑膜形成纤维粘连。术后形成的纤维粘连会导致并发症，由于再次手术、术后肠梗阻、不孕不育和慢性疼痛的发生率增加，显著增加了医疗费用。尽管需要抗粘连治疗，但目前还没有FDA批准的预防设备来有效防止脊柱和腹腔镜手术后的手术粘连。针对预防粘连的治疗获得FDA批准的一个障碍是缺乏良好的临床终点措施来评估治疗效果。NovelMed开发了一种新型合成碳水化合物NM2040，它基于之前的合成阴离子碳水化合物Adcon，尽管成功地抑制了粘连，但已有显著副作用的报道。NovelMed最近发现Adcon对血小板有毒性。鉴于血小板在止血和伤口愈合中的关键作用，Adcon的副作用可能与血小板毒性有关。NM2040是为了克服Adcon对血小板的毒性作用而开发的。初步研究结果表明，这种生物相容的结合物可以有效地抑制手术粘连，防止与纤维化相关的细胞侵袭和增殖到手术部位，而不会产生血小板毒性。本应用程序的目标是1)测试使用NM2040作为预防手术粘连的治疗方法的可行性，该方法采用经过验证的腰椎椎板切除术模型；2)开发一种妇科粘连的手术粘连模型，该模型具有良好的临床终点措施；以及确定NM2040预防输卵管粘连的有效性。我们的最终目标是开发一种FDA批准的用于背部和腹部手术的有效防粘连装置。 公共卫生相关性：术后粘连形成是手术最大的并发症。在美国，每年有2700万例外科手术，患者面临并发症的风险，这些并发症由于再次手术率增加、术后肠梗阻、不孕不育和慢性疼痛而显著增加医疗费用。本应用程序的目标是1)测试使用NM2040作为预防手术粘连的治疗方法的可行性，该方法采用经过验证的腰椎椎板切除术模型；2)开发一种妇科粘连的手术粘连模型，该模型具有良好的临床终点措施；以及确定NM2040预防输卵管粘连的有效性。我们的最终目标是开发一种FDA批准的用于背部和腹部手术的有效防粘连装置。