NCT02053168已完成不适用
A Prospective, Multicenter All Comers Study of a Novel Resorbable Mesh (Phasix Mesh) for Ventral or Incisional Hernia Repair
C. R. Bard12 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2014年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 12
- 主要终点
- Number of Participants With Hernia Recurrence
研究概览
简要总结
Collect data on safety, performance, and effectiveness of Phasix Mesh in subject requiring primary ventral and incisional hernias.
详细描述
Pilot Study of patients across all wound classes for recurrence
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Subject or subject's legally authorized representative must be willing to give written informed consent
- •Subject must be diagnosed with ventral or incisional hernia
- •Subject must be willing to undergo open ventral hernia repair and be able to undergo all other study procedures as outlined in this protocol.
排除标准
- •Subject is an active smoker (if attempts to quit smoking within two weeks of surgery have failed and the patient is still an active smoker at the time of surgery).
- •Subject's hernia has recurred four or more times.
- •Subject's body mass index (BMI) >40 kg/m
- •Subject has peritonitis.
- •Subject is on or suspected to be placed on chemotherapy medications during any part of the study.
- •Chronic steroid use or immunosuppression drugs (> 6 months).
- •Subject has cirrhosis, and/or ascites.
- •Subject is American Society of Anesthesiology Class 4 or
- •Subject is pregnant or planning to become pregnant during the course of the study.
- •Subject is known to be infected with human immunodeficiency virus (HIV).
- •Subject has a life expectancy of less than 2 years at the time of enrollment.
- •Subject has been treated with an investigational product in the past 30 days.
- •Subject is part of the site personnel directly involved with this study
- •Subject has a known allergy to tetracycline hydrochloride or kanamycin sulfate, the test device or its component materials.
- •Subject has any condition that in the opinion of the Investigator would preclude the use of the study device, or preclude the subject from completing the follow-up requirements
结局指标
主要结局
Number of Participants With Hernia Recurrence
时间窗: 1 Month, 3 Months, 6 Months, 12 Months, 18 Months, 24 Months, >24 Months
A recurrent hernia was defined as any hernia identified or confirmed by the investigator, during any study follow-up visit, in approximately the same position as the hernia repaired in the study procedure. Potential hernias identified via incidental magnetic resonance imaging (MRI) or computed tomography (CT) scan were evaluated by the operating surgeon for clinical significance and confirmation of hernia recurrence.
次要结局
- Surgical Procedure Time(Duration of index procedure (mean of 242.5 mins))
- Number of Study Related Post Operative Surgical Procedures(24 Months)
- Number of Participants With Device Related Adverse Events(24 Months)
- Short Form (SF)-12 Version 2 - Mental Component Summary (Change From Baseline)(Baseline and 24 months postoperative)
- Number of Study Related Post Operative New Hospital Admissions(24 Months)
- Carolinas Comfort Scale (CCS) Total Score - Change From Baseline(Baseline and 24 months postoperative)
- Number of Related Post-operative Visits Unrelated to Standard of Care(24 Months)
- Incidence of Seroma(24 Months)
- Short Form (SF)-12 Version 2 - Physical Component Summary (Change From Baseline)(Baseline and 24 months postoperative)
- Length of Hospital Stay(10 Months)
研究者
研究点 (12)
Loading locations...
相似试验
已完成
不适用
Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia RepairHernia, AbdominalHerniaHernia, IncisionalNCT02720042C. R. Bard84
已完成
不适用
A Prospective, Observational Study Utilizing Phasix™ Mesh During Ventral and Incisional Hernia Repair SurgeryVentral HerniaNCT01863030John Roth31
进行中（未招募）
不适用
Prophylactic Reinforcement of Ventral Abdominal Incisions TrialOpen Midline LaparotomyNCT03911700C. R. Bard477
已完成
不适用
A Prospective, Multi-Center Study of Phasix™ Mesh for Ventral or Incisional Hernia Repair.Ventral HerniaIncisional HerniaNCT01961687C. R. Bard121
已完成
不适用
Self-Expanding Multi-Layered Partially Resorbable Lightweight Polypropylene Mesh Device (Proceed Ventral Patch® Or Pvp®) For The Treatment of Small and Medium Umbilical Ventral HerniasUmbilical HerniaNCT01307696Algemeen Ziekenhuis Maria Middelares100