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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Eddie Shaw
- 電話番号：201 744 6062
- メール：eddie.shaw@gordiansurgical.com
研究場所
-
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Pennsylvania
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Pittsburgh、Pennsylvania、アメリカ、15212
- AHN Allegheny General Hospital
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主任研究者：
- James McCormick, DO
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コンタクト：
- James McCormick, DO
- 電話番号：412-687-7348
- メール：james.mccormick@ahn.org
-
コンタクト：
- Clinical Trials Contact
- 電話番号：412-687-7348
- メール：clinicaltrials@ahn.org
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副調査官：
- Richard Fortunato, DO
-
-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：なし
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：Interventional - TroClose1200 with DaVinci Robot
This intervention will assess affective fascial closure utilizing the TroClose1200 device in DaVinci Robotic procedures.
|
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
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
時間枠：30 days
|
Measured by confirmation of fascial closure by digital (finger) palpation - Measured as either closed or not closed.
|
30 days
|
|
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
時間枠：30 days
|
Measured by confirmation of fascial closure by visual inspection - Measured as either closed or not closed.
|
30 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Safety; Freedom from peri operative serious adverse events
時間枠：30 days
|
serious adverse events
|
30 days
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- AHN-GOR 001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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