NL-OMON45486已完成不适用
Efficacy and Safety of LifeSeal* Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study. - LifeSeal Pivotal study
ifeBond Ltd.0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •1. Male or female * 21 years of age at Screening Visit.
- •2. Written informed consent obtained from subject or subject*s legal representative and ability for subject to comply with the requirements of the study.
- •3. Subject is diagnosed with colorectal cancer
- •4. Subject is scheduled for elective open, laparoscopic or robot assisted surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
- •5. Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
- •6. Female subjects in child bearing age must be using acceptable contraception methods such as hormonal contraception or two forms of barrier contraception. Acceptable contraception must be used consistently from 30 days before screening until 3 years following surgery.
排除标准
- •Pre-operative exclusion criteria:
- •1. Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
- •2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data.
- •3. Subject has a history of hypersensitivity to porcine derived gelatin or collagen.
- •4. Subject has a history of hypersensitivity to microbial Transglutaminase.
- •5. Subject has a known dysfibrinogenimeia, hypofibrinigenimia or a fibrinogenimia, without preoperative correction of fibrinogen levels.
- •6. Subject participating in any other study involving an investigational (unapproved) drug or device within the past 60 days.
- •7. Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
- •8. Subject with a BMI *50, which may interfere with access to the surgical site and increase overall operative risk.
- •9. Subject with American Society of Anesthesiology (ASA) status higher than 3.
- •10. Avastin use within 30 days prior to surgery.
- •11. Subject who has undergone a prior pelvic anastomosis.
- •12. Subject is scheduled for another surgery during the first 6 months following surgery (not including stoma closure,placement of port for chemotherapy or ureter stent insertion).
- •13. Subject with an active abdominal or pelvic infection at the operation site.
- •14. Subject has been previously treated with LifeSeal* Surgical Sealant.;Intra-operative Exclusion Criteria
- •1. Anastomosis or procedure (TME) was performed differently from what was defined in the inclusion criteria.
- •2. Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal* Surgical Sealant.
- •3. Subject has peritoneal carcinomatosis.
- •4. Subject requires additional unrelated anastomosis during the surgery.
- •5. Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
- •6. Excessive bleeding (above 500cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion.
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