NCT01305486终止不适用
A Prospective, Multi-Center Study of Complex Ventral Hernia Repair Utilizing the XenMatrix™ Surgical Graft With Component Separation
C. R. Bard1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery.
研究概览
简要总结
This will be an observational study designed to collect early, short- and long-term clinical outcomes of the XenMatrix™ Surgical Graft for complex ventral hernia repair. Subjects will be expected to attend follow up visits at 1, 6, 12, 18 and 24 months following surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able to undergo study procedures.
- •Have signed an Informed Consent form (ICF).
- •Be diagnosed with a ventral or incisional hernia that cannot be closed primarily in the opinion of the investigator.
- •Requires a component separation repair with the use of a biological graft.
排除标准
- •Subject is participating in another device or drug study.
- •Subject has a life expectancy less than 4 years at the time of enrollment.
- •Any condition in the opinion of the investigator that would preclude the use of the XenMatrix™ Surgical Graft, or preclude the subject from completing the follow-up requirements.
- •Any subject with a defect the surgeon feels he/she cannot fully close.
- •Subjects with a BMI >
- •Subjects with connective tissue disorders.
- •Subjects with a history of cirrhosis.
- •Subjects with renal failure requiring dialysis.
- •Subjects on or suspected to be placed on chemotherapy or systemic immunosuppressive medications during any part of the study.
- •Transplant recipients.
- •Subjects taking corticosteroids for >6 months (pre or post surgery).
- •Any bowel leak or infection that would preclude the use of the XenMatrix™ Surgical Graft in the opinion of the investigator.
- •The subject lives approximately 2 hours away from the study site and compliance with follow up requirements will be difficult in the opinion of the investigator.
结局指标
主要结局
To estimate the hernia recurrence rate of complex ventral hernias post repair with the XenMatrix™ Surgical Graft utilizing the component separation technique with several different tissue plane placements of the graft for up to 24 months post surgery.
时间窗: 2 Years
Any hernia which is identified or confirmed by the investigator in approximately the same position as the hernia repair during any follow up visit after a XenMatrix™ surgical graft has been placed will be considered a recurrent hernia.
次要结局
- To assess the procedural time for XenMatrix™ Surgical Graft placement with component separation.(Day 0)
- To assess perioperative, short-term and long-term complications in subjects with complex hernias repaired with XenMatrix™ Surgical Graft and component separation.(2 Years)
- To assess changes in subject quality of life (QOL) post repair with a XenMatrix™ Surgical Graft with component separation.(2 years)
- To assess clinical outcomes based on the tissue plane placement of the XenMatrix™ Surgical Graft.(2 years)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
A prospective, multicenter, observational study: validity of modified treatment strategy for neonatal jaundice in Japaneonatal jaundiceJPRN-UMIN000021057Kobe University6,000
已完成
不适用
Multicenter Retrospective Observational Study of Acute Myocarditis in KoreaMyocarditis AcuteNCT05933902Samsung Medical Center841
已完成
不适用
A Prospective and Observational Cohort Study to Evaluate the Treatment Model and Medical Economics of Advanced Gastric Cancer Chemotherapy in Clinical Practice in ChinaAdvanced Gastric CancerNCT01472250Peking University498
已完成
不适用
Secondary Prevention of Osteoporotic Fractures: a Multiple Center Fracture Liaison Service in GreeceOsteoporosisNCT02637180Hellenic Society for the Study of Bone Metabolism397
进行中（未招募）
不适用
To Evaluate the Efficacy and Safety of Envlo Tablet or Envlomet SR Tablet in Patients With Type II Diabetes MellitusDiabetes Mellitus, Type 2NCT05926414Daewoong Pharmaceutical Co. LTD.15,000