A Prospective Multi-Center Clinical Study to Evaluate the Safety of Progel® Pleural Air Leak Sealant in Video Assisted and Robotic Assisted Thoracotomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 207
- 试验地点
- 18
- 主要终点
- Rate of Device and/or Procedure-related Adverse Events
研究概览
简要总结
The objective of this clinical study is to evaluate the safety of the Progel® PALS, including the Progel® Extended Applicator Spray Tips, in sealing or reducing intraoperative air leaks in patients undergoing video assisted or robotic assisted thoracoscopic (VATS/Robotic) surgeries.
The data collected in this clinical study will supplement the Approved PMA P010047 Progel® PALS product.
详细描述
This is a prospective, open label, multi-center clinical study designed to assess the safety of the Progel® PALS product, including the Extended Applicator Spray Tip, when used in Video Assisted and Robotic Assisted Thoracoscopic Surgery. The study will treat approximately 105 evaluable subjects at up to 15 U.S. sites. All subjects will provide informed consent prior to enrollment in the study.
Patients who have met the initial screening criteria and who have a visible pleural air leak which requires treatment with a sealant, after standard closure techniques are used (standard sutures, staples or devices supplied by the hospital for thoracoscopic surgery) will be eligible for study participation. If the subject is treated, the surgeon will utilize Progel® PALS to the same sites originally treated with standard technique.
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 is willing and able to provide written informed consent.
- •Subject is scheduled for video assisted or robotic assisted thoracoscopic surgery for lung resection (i.e. lobectomy, bilobectomy, segmentectomy, and wedge resection/lung volume reduction), decortications or biopsy within 45 days of the screening evaluation.
- •Subject is ≥18 years of age.
- •Subject has a life expectancy ≥6 months.
- •Following lung resection, subject has at least one or more visible intraoperative air leaks, after standard closure techniques are applied, that requires treatment with pleural sealant.
- •Subject is willing and able to comply with the study procedures and complete the entire study as specified in the protocol, including the follow-up visits.
排除标准
- •Subject has undergone previous lung resection or previous use of a sealant for air leaks.
- •Subject has a serum creatinine ≥2.5 mg/dl at baseline or is currently on dialysis.
- •Following lung resection, subject has intraoperative air leaks that require non-standard, visceral pleural closure (e.g. leak is too small or tissue is too fragile to use sutures/staples).
- •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.
- •Subject has known allergy to human albumin or any component in the Progel® PALS product.
- •Subject has an active or latent infection which is systemic or at the intended surgery site.
- •Subject has necrotic or friable borders of the defect that will not support secure suture fixation if use of sutures is required.
- •Subject is participating in another investigational drug or device trial.
- •Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
- •Subject is part of the site personnel directly involved with this study.
- •Subject is a family member of the investigational study staff.
结局指标
主要结局
Rate of Device and/or Procedure-related Adverse Events
时间窗: One (1) month follow-up
The primary outcome of the study is the rate of device- and/or procedure-related adverse events at one month after surgery in subjects using Progel® PALS in a VATS/Robotic procedure. Endpoint analysis of the rate of device- and/or procedure-related adverse events will be based on the Clinical Events Committee (CEC) adjudication of adverse events.
次要结局
- Duration of Chest Tube Drainage(Day 0-46)
- Number of Subjects Who Are Free From Air Leaks Immediately Following Surgery(Day 0)
- Duration of Hospitalization (Length of Stay)(Days 0-20)
- Duration of Postoperative Air Leaks From the Time of Surgery Until the Air Leak Seals(Day 0-46)
- Percentage of Subjects Without Postoperative Air Leaks Following Lung Surgery up to One (1) Month Follow-up(One (1) month)
- Percentage of Air Leaks That Are Sealed or Reduced(Day 0)
- Patient Reported Quality of Life as Measured by the SF-36 at Change From Baseline at One(1) Month Follow up(Baseline and One (1) Month Follow-up)