Prospective, Multi-center, Single-arm, Open Label Study Designed to Assess the Safety and Feasibility of the MACS in Surgery Procedures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Number of Participants with Device and/or Procedure Related Adverse Events
研究概览
简要总结
The goal of this clinical trial is to evaluate the safety and performance of the MACS device in adults undergoing elective plastic surgery procedures. Participants will undergo their planned surgical procedure in which the MACS device will be used as part of the procedure. Participants will be monitored during and after surgery to assess device performance and to identify any medical problems (adverse events) that may occur following use of the device.
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
- 是
入选标准
- •At least 18 years of age
- •Scheduled to undergo elective surgery procedure within a study cohort
- •Willing and able to provide written Informed Consent Form (ICF) to participate in the study prior to any study required procedures
排除标准
- •Significant comorbidities: e.g. cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure).
- •Individuals with pacemakers, defibrillators, or other electromedical implants.
- •Individuals with ferromagnetic implants.
- •Clinical history of impaired coagulation confirmed by abnormal blood tests.
- •Pregnant or wishes to become pregnant during the length of study participation.
- •Individual is not likely to comply with the follow-up evaluation schedule.
- •Participating in a clinical trial of another investigational drug or device.
研究组 & 干预措施
MACS-Assisted Surgical Procedure
Participants will undergo the planned surgical procedure utilizing the MACS system in accordance with the study protocol and device Instructions for Use (IFU). The MACS will be used as intended to support the surgical procedure. All participants will receive the intervention; no comparator arm is included. Safety and feasibility endpoints will be assessed perioperatively and during the defined follow-up period.
干预措施: MACS System (Device)
结局指标
主要结局
Number of Participants with Device and/or Procedure Related Adverse Events
时间窗: From enrollment to end of follow up at 30 days.
Adverse events will be summarized by relatedness to the device and/or procedure, seriousness and level of severity.
Average Number of Ports
时间窗: During index procedure.
Ability to adequately retract tissue to achieve an effective exposure of the target tissue. Adequate retraction will be deemed to be achieved if there is a reduction of the incision size or at least one conventional retractor is avoided compared to the investigator's standard practice.
次要结局
未报告次要终点