EUCTR2009-010095-23-DE进行中（未招募）不适用
A prospective, controlled, randomized, multi-center, pivotal study evaluating the safety and efficacy of ADHEXIL in prevention and/or reduction of adhesions in gynecology surgery
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Female patients aged 18-45 years at screening.
- •2. Patients scheduled for elective laparoscopic gynecology surgery involving at least one adnexa, due to ovarian cysts and/or endometriosis and/or prior inflammation and/or existing adhesions.
- •3.Patients must be willing to participate in the study, and provide written informed consent.
- •4.Patients must be available and willing to undertake study visits and procedures.
- •5.Patients of child-bearing potential must be using a medically acceptable method of birth control until the date of the 2LL.
- •6.Patient must have at least one adnexa (ovary and its adjacent tube
- •Intra-Operative Inclusion Criteria
- •1. Patient must have at least one adnexa (ovary and its adjacent tube)
- •2. Raw surface involving at least 1cm2 of adnexa surface prior to suturing/cautery.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Pregnant (including current ectopic pregnancy) or breastfeeding patient.
- •2.Patients whose 1LL procedure would involve surgical sterilization.
- •3.Patients whose 1LL procedure would involve hysterectomy.
- •4.Patients with a lymphatic, hematologic or coagulation disorder.
- •5.Patients with a known or suspected hypersensitivity to blood, blood products or any constituent of ADHEXIL™.
- •6.Patients whose pre-operative laboratory values at the baseline visit are out of normal ranges and are clinically significant, as classified by the investigator.
- •7.Patients who are immunocompromised, possess autoimmune disorders.
- •8.Patients who are routinely taking anticoagulants.
- •9.Patients who have participated in another clinical study within 30 days of enrolment.
- •10.Investigator’s opinion that the patient is medically unfit or would be at major risk if enrolled into the study.
- •11.Patients with American Society of Anesthesiologists class > 2 (see appendix B for classification).
- •12.Patients with a known or suspected hypersensitivity to Indigo Carmine
- •13.Patients diagnosed with adnexal cancer
- •Intra-Operative Exclusion Criteria
- •1. Presence of active infection.
- •2.Use of heparin-containing irrigants.
- •3.Use of other agents for the purpose of reducing adhesions, including corticosteroids, anticoagulants, and nonsteroidal anti-inflammatory agents.
- •4.Use of INTERCEED, SprayGel, Seprafilm, ADEPT, Hyskon, Oxiplex or any other adhesion reduction agent.
- •5.Patients whose 1LL procedure would involve enterotomy and/or cystotomy and/or urostomy, and/or postoperative hydrotubation.
- •6.Patients in whom a procedure required conversion to laparotomy.
- •7.Use of any topical hemostatic agents that are left behind in the body or use of catgut, chromic catgut, or nonresorbable sutures on the ovaries or tubes or immediately adjacent structures.
- •8.Use of gasless laparoscopy.
- •9.Performance of non-gynecologic surgical procedure (e.g. cholecystectomy).
- •10.Investigator’s opinion that a second look is not in the best interest of the patient.
研究者
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