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Adhesions in gynecology surgery. Surgeries involved will be ovarian cystectomy, endometriosis, inflammation, adhesiolysisOvarian adhesion MedDRA 10067156Tubal rupture MedDRA 10067553MedDRA version: 9.1Level: LLTClassification code 10014778Term: EndometriosisMedDRA version: 9.1Level: LLTClassification code 10004433Term: Benign ovarian tumourMedDRA version: 9.1Level: LLTClassification code 10053865Term: Benign fallopian tube neoplasmMedDRA version: 9.1Level: LLTClassification code 10050697Term: Fallopian tube cystMedDRA version: 9.1Level: LLTClassification code 10061855Term: Fallopian tube neoplasmMedDRA version: 9.1Level: LLTClassification code 10048991Term: Ovarian adenomaMedDRA version: 9.1Level: LLTClassification code 10033132Term: Ovarian cystMedDRA version: 9.1Level: LLTClassification code 10033136Term: Ovarian cyst rupturedMedDRA version: 9.1Level: LLTClassification code 10064257Term: Ovarian fibromaMedDRA version: 9.1Level: LLTClassification code 10033236Term: Ovarian germ cell teratoma benignMedDRA version: 9.1Level: LLTClassification code 10061535Term: Ovarian neoplasmMedDRA version: 9.1Level: LLTClassification code 10052456Term: Parovarian cystMedDRA version: 9.1Level: LLTClassification code 10036049Term: Polycystic ovariesMedDRA version: 9.1Level: LLTClassification code 10033139Term: Ovarian disorderMedDRA version: 9.1Level: LLTClassification code 10033263Term: Ovarian haematomaMedDRA version: 9.1Level: LLTClassification code 10065741Term: Ovarian haemorrhageMedDRA version: 9.1Level: LLTClassification code 10058823Term: Ovarian massMedDRA version: 9.1Level: LLTClassification code 10033277Term: Ovarian prolapseMedDRA version: 9.1Level: LLTClassification code 10033279Term: Ovarian ruptureMedDRA version: 9.1Level: LLTClassification code 10046988Term: Varicocele ovarianMedDRA
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Adhesions in gynecology surgery. Surgeries involved will be ovarian cystectomy, endometriosis, inflammation, adhesiolysisOvarian adhesion MedDRA 10067156Tubal rupture MedDRA 10067553
- 发起方
- Omrix Biopharmaceuticals Ltd
- 入组人数
- 80
- 状态
- 进行中（未招募）
- 最后更新
- 14年前
概览
简要总结
暂无简介。
研究者
入排标准
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
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.
结局指标
主要结局
未指定
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