GRIP: Gordian Robotic Integrated Port Closure Study (GRIP)
Gordian Robotic Integrated Port Closure Using the TroClose™ 1200 With the da Vinci® 12 mm Robotic Assistant Port
The GRIP (Gordian Robotic Integrated Port Closure) Study is a prospective, single-arm feasibility study evaluating the use of the TroClose™ 1200 device for closure of da Vinci® 12 mm robotic assistant port sites following robotic-assisted surgical procedures.
TroClose™ 1200 is an FDA-cleared medical device designed to facilitate fascial closure of laparoscopic and robotic access ports. The device deploys anchors and suture at the beginning of the procedure, allowing closure to be completed at the end of surgery without the need for additional needle passage or specialized closure instruments.
The purpose of this study is to assess the safety, feasibility, procedural performance, and clinical outcomes associated with use of the device in patients undergoing robotic-assisted surgery. Study assessments will include successful port-site closure, device-related adverse events, post-operative complications, and short-term follow-up evaluations.
Approximately 26 adult participants undergoing robotic-assisted surgical procedures at Allegheny Health Network will be enrolled.
研究概览
详细说明
GRIP (Gordian Robotic Integrated Port Closure) is a prospective feasibility study evaluating the use of the TroClose™ 1200 device for closure of da Vinci® 12 mm robotic assistant port sites following robotic-assisted surgical procedures.
TroClose™ 1200 is an FDA-cleared Class II medical device designed to facilitate fascial closure of laparoscopic and robotic access ports. The device deploys fixation anchors and suture during port insertion, allowing closure of the fascial defect at the completion of the procedure without the need for additional needle passage through the abdominal wall. This approach is intended to provide a standardized and reproducible closure technique while minimizing additional procedural steps at the conclusion of surgery.
Robotic surgery continues to expand across multiple surgical specialties, resulting in increased utilization of 12 mm robotic assistant ports. Appropriate closure of fascial defects associated with larger trocar sites remains an important consideration for reducing port-site complications and maintaining procedural efficiency. The GRIP study is designed to evaluate the performance of a pre-positioned closure system within the robotic surgical environment.
Participants undergoing eligible robotic-assisted surgical procedures will receive closure of a designated da Vinci® 12 mm assistant port using the TroClose™ 1200 device according to the study protocol. The study will assess device utilization within routine clinical practice and characterize procedural performance, workflow integration, and safety outcomes associated with use of the device in robotic-assisted surgery.
Data generated through this investigation will contribute to the understanding of pre-positioned fascial closure techniques for robotic surgery and may inform future clinical studies, publications, and broader adoption of robotic port-site closure technologies.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Eddie Shaw
- 电话号码：201 744 6062
- 邮箱：eddie.shaw@gordiansurgical.com
学习地点
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15212
- AHN Allegheny General Hospital
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首席研究员：
- James McCormick, DO
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接触：
- James McCormick, DO
- 电话号码：412-687-7348
- 邮箱：james.mccormick@ahn.org
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接触：
- Clinical Trials Contact
- 电话号码：412-687-7348
- 邮箱：clinicaltrials@ahn.org
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副研究员：
- Richard Fortunato, DO
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-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Males or female patients age 18 to 95 years old
- Scheduled to undergo an elective, clinically indicated robotic surgery with a da Vinci® 12 mm assistant port
- Trocar site is appropriate for TroClose™ per Investigator/Surgeon discretion
- Subject is able and willing to sign a written informed consent form
Exclusion Criteria:
- Scheduled to undergo emergency surgery
- Weight under 45kg (99.2 pounds)
- Infection at port site
- Prior surgical mesh at intended incision location
- Surgeon-determined contraindication for use of the TroClose™ 1200
- Inability to provide written, informed consent
- Known allergy to PGA (Polyglycolic Acid)
- PLA (Polylactic Acid).
学习计划
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Interventional - TroClose1200 with DaVinci Robot
This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Technical Success; To determine the ability of the TroClose™ 1200 to achieve fascial closure when used with a 12mm da Vinci® robotic assistant port during robotic surgery
大体时间：30 days
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Measured by confirmation of fascial closure by digital (finger) palpation - Measured as either closed or not closed.
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30 days
|
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Technical Success; To determine the ability of the TroClose™ 1200 to achieve fascial closure when used with a 12mm da Vinci® robotic assistant port during robotic surgery
大体时间：30 days
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Measured by confirmation of fascial closure by visual inspection - Measured as either closed or not closed.
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30 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety; Freedom from peri operative serious adverse events
大体时间：30 days
|
serious adverse events
|
30 days
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- AHN-GOR 001
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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