Post-market Clinical Follow-up Study of REusable Clip Applier and Cartridge Devices for LAParoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 7
- 主要终点
- No Post-Operative Leakage of Ligation Sites
研究概览
简要总结
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery. This system consists of two medical devices, the M/L-10 Clip Applier and the M/L-10 Clip. The Multi-Fire Clip System is indicated for occluding and ligating vessels, ducts, tracts and other tubular structures during laparoscopic and general surgical procedures. This medical device has been marketed in Europe since 2006 and in the United States since 2002, among other places.
Laparoscopic surgeries have become the standard of excellence for many surgical procedures as they allow the intervention to be performed in a minimally invasive way, which means significant improvements in factors such as postoperative pain or length of hospital stay compared to open surgeries. Laparoscopic procedures require the use of different hemostatic techniques to minimize blood loss or leakage of other fluids through their respective ducts. Currently, clip and staple placement are the most commonly used procedures for ligation and/or occlusion of blood vessels and other tubular structures.
In this context, the Multi-Fire Clip System is presented as an alternative device that can produce significant cost savings due to the reusable design of the M/L-10 Clip Applier. It also provides precise control of bleeding during surgery, which could lead to less potential injury to surrounding structures.
The present clinical trial is a PMCF study to evaluate the long-term safety and efficacy of the Multi-Fire Clip System in patients scheduled to undergo laparoscopic surgery in which clip placement is anticipated. During the surgery procedure, the necessary clips will be placed using the aforementioned multi-shot clip system. Participants will be followed up for 6 months after the operation. Through an on-site visit and a telephone call visit, data on possible adverse events related to the device or procedure will be collected in order to assess the long-term safety and efficacy of these devices.
详细描述
The RELAP PMCF will be conducted as a prospective, single-arm, open-label and multi-center clinical investigation and will include up to 230 subjects derived for laparoscopic surgery. The clinical investigation will be conducted in up to 12 sites located in European countries. Additional sites or other countries may be approached for participation in the clinical investigation if needed.
The primary objective of the RELAP Post-Market Clinical Follow-Up Study is to determine the long-term effectiveness of the Multi-Fire Clip System through 6-months follow-up. The secondary objective of the RELAP Post-Market Clinical Follow-Up Study is focused on the long-term evaluation of Multi-Fire Clip System safety and effectiveness through the collection of Serious Adverse Events (SAEs) and Major Adverse Events (MAEs) related to both the medical device and the procedure.
The primary safety and efficacy endpoint is the efficacy of long-term vessel/duct ligation defined as absence of Adverse Events (AEs) related to vessel and/or duct leakage due to incomplete ligation of the vessel/duct after appropriate placement of clip at 6 months in patients indicated for laparoscopic surgical procedure.
There are several secondary endpoints planned for his clinical investigation. Firstly, all serious adverse events (SAEs) will be evaluated at 6 months. Additionally, a long-term evaluation of major adverse events (MAEs) related to both the medical device and the procedure. A Risk Ratio (RR) will be defined for the analysis of this secondary endpoint. The time frame for the long-term evaluation will be 30-days follow-up and 6-months follow-up. Moreover, the Acute Procedural Success (APS), defined as the absence of (S)AEs within 24h after the surgery, will be assessed. The Acute Device Success, defined as the absence of (S)AEs related to the devices within the 24h after the surgery will also be evaluated. Finally, the Length of Stay (LoS) in the hospital will be evaluated.
The Clinical Investigation visits will occur at Baseline, Procedure and 30-days follow-up, with a final phone call at 6 months will take place. This clinical investigation will enroll male and female adult subjects who have been scheduled for a laparoscopic surgery using a clip. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care. The target population are subjects that require a laparoscopic surgery and a clip can be used to occlude a vessel/duct. Approximately 230 subjects will be enrolled in the clinical investigation in order to assess the primary endpoint. The expected duration of enrollment is up to 12 months. The expected duration of each subject's participation is 6 months, including the scheduled visits and data collection for this clinical investigation that will occur during the "early follow-up visit" at 30 days after the procedure and 6 months. The subject follow-up will be considered completed at the conclusion of their 6-month follow-up visit. Therefore, the total duration of the clinical investigation is expected to be 18 months.
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
- •Adult subjects, male or female, ≥18 years old
- •Subjects who have been scheduled for a laparoscopic surgery using the clip
- •Subjects who had provided written informed consent form
- •Ability and willingness to comply with all study requirements to be evaluated for each study visit
排除标准
- •Subjects referred for laparoscopic surgeries to reinforce a staple line or produce partial vessel occlusion
- •Significant surgical contraindications evaluated using the GOALS score
- •Subjects unsuitable for laparoscopic surgery according to PI discretion
- •Subjects who have coagulopathy or uninterruptible anticoagulation therapy
- •Subjects currently under steroid treatment
- •Subject has known allergy to device components (i.e., titanium, stainless steel)
- •Subjects who are participating in another trial which may affect the outcomes data on this study
- •Inability to adhere to study-related procedures
- •Subjects that require emergency surgeries associated with trauma and/or sepsis with a SOFA score ≥ 2 and/or septic shock should be excluded
- •Pregnant or lactating women at the time of the surgery
研究组 & 干预措施
Laparoscopic Surgical Patients
- Adult subjects, male or female, ≥18 years old
- Subjects who have been scheduled for a laparoscopic surgery using the clip
- Subjects who had provided written informed consent form
- Ability and willingness to comply with all study requirements to be evaluated for each study visit
干预措施: M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System) (Device)
结局指标
主要结局
No Post-Operative Leakage of Ligation Sites
时间窗: 6 months after laparoscopic surgical procedures
Efficacy of long-term vessel/duct ligation defined as absence of Adverse Events (AEs) related to vessel and/or duct leakage due to incomplete ligation of the vessel/duct after appropriate placement of clip at 6 months of laparoscopic surgical procedures. Assessment of leakage was based on follow-up inquiry six months after the ligation procedure.
次要结局
- Acute Procedural Success (APS)(One day (during procedure))
- Acute Device Success (ADS)(One day (during procedure))
- Long-term Evaluation of Major Adverse Events (MAEs) Related to the Medical Device or Procedure With 30-days Follow-up(30-days follow-up)
- All Serious Adverse Events (SAEs) With 30 Days Follow-up(30 days follow-up follow-up after laparoscopic surgical procedures)
- Long-term Evaluation of Major Adverse Events (MAES) Related to the Medical Device or Procedure With 6-month Follow-up(6-months follow-up)
- Length of Stay (LoS) in Hospital(Up to 30 days)
- All Serious Adverse Events (SAEs) With 6 Months Follow-up(6 month follow-up after laparoscopic surgical procedures)