NCT04299282撤回不适用
A Prospective, Randomized, Single-Center Study Evaluating CanGaroo in Low BMI Patients Undergoing Pacemaker, ICD, or S-ICD Implantation
适应症
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.
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
- QOL Survey(3 months post CIED implantation)
- Skin Fold Test(3 months post CIED implantation)
- Vascular Tissue Layer(3 months post CIED implantation)
研究者
相似试验
撤回
4 期
Effectiveness of Aurix Therapy in Venous Leg UlcersVenous Leg UlcersNCT02940587Cytomedix
Unknown
不适用
Effectiveness of Aurix Therapy in Diabetic Foot UlcersDiabetic Foot UlcersNCT02352480Nuo Therapeutics760
Unknown
不适用
Effectiveness of Aurix Therapy in Venous Leg UlcersVenous Leg UlcersNCT02352454Nuo Therapeutics640
Unknown
不适用
Effectiveness of Aurix Therapy in Pressure UlcersPressure UlcerNCT02352467Nuo Therapeutics800
已完成
1 期
Allogeneic ABCB5-positive Stem Cells for Treatment of CVUSkin Ulcer Venous Stasis ChronicNCT03257098RHEACELL GmbH & Co. KG31