A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Elutia Inc.
- 主要终点
- Healing at incision site
研究概览
简要总结
The primary objective is to demonstrate a better degree of healing at the incision site and a decrease in erosion with CanGaroo compared to control patients (no envelope, CIED alone).
详细描述
A single-center, prospective, randomized, post-market study of patients undergoing implantation of a pacemaker, ICD, or S-ICD with or without CanGaroo using the same hydration solution. Twenty patients, randomized 1:1 for 10 in the treatment group and 10 in the control group, shall be enrolled. Follow-up visits include post-op and 3-months following the implantation procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI of less than
- •Already scheduled for or a clinical decision made to have one of the following qualifying CIED implant procedures using a device cleared by the U.S. FDA:
- •De novo pacemaker, ICD, or S-ICD;
- •Upgrade or change out of existing CIED to a pacemaker, ICD, or S-ICD
- •Clinically stable and able to tolerate procedure.
- •Be able and willing to return for follow-up care through the 3-month visit.
- •Must possess the ability to provide informed consent.
排除标准
- •Patients with a known sensitivity to porcine material.
- •Participation in another clinical study.
- •Active infection. Clinical diagnosis of an active infection at the time of CIED implant (CIED infection, pneumonia, UTI, endovascular, cellulitis, bacteremia, or other major systemic infection).
- •Female patient who is pregnant, or planning to become pregnant during the length of the study.
- •Prior history of a CIED infection, other prosthetic device infection, or endovascular infection, including endocarditis in the past 12 months.
- •Life expectancy of less than 3 months.
研究组 & 干预措施
CanGaroo
The treatment group will receive a CanGaroo envelope with implantation of a CIED
干预措施: CanGaroo (Device)
No CanGaroo
The control group will not receive a CanGaroo envelope with implantation of a CIED
结局指标
主要结局
Healing at incision site
时间窗: 3 months post CIED implantation
Improved incision site healing for the CanGaroo group
次要结局
- Vascular Tissue Layer(3 months post CIED implantation)
- QOL Survey(3 months post CIED implantation)
- Skin Fold Test(3 months post CIED implantation)