Post Market Study for FloShield 10mm Reusable Cannula and Blunt Obturator and Robotic FloShield

Study Overview
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Brief Summary
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This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.

Official Title
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Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison

Conditions
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Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy

Intervention / Treatment
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* Device: Cannula and Blunt Obturator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 years or older Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator Suitable candidate for surgery Is able to read and understand the informed consent form and has voluntarily provided written informed consent Exclusion Criteria: Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator) Subjects with known allergy (hypersensitivity) to Docusate Sodium Use of Surgiquest AirSeal during the laparoscopic single-site surgery Use of humidified insufflation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 10mm Cannula<br>Subjects that are scheduled for a robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator | Device: Cannula and Blunt Obturator<br>* The FloShield 10mm Endoscopic Cannula and Blunt Obturator will be used to maintain access to the peritoneal cavity during robot-assisted single site laparoscopic surgery<br>* Other names: FloShield Blunt Oburator, FRT10B;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Completion rate | Completion rate is the percentage of users who successfully complete the task without critical errors. A critical error is defined as an error that results in an incorrect or incomplete outcome (Grade 1 and 2). In other words, the completion rate represents the percentage of participants who, when they are finished with the specified task, have an output that is correct (Grade 3 - 5). Note: If a participant requires assistance in order to achieve a correct output then the task will be scored as a critical error and the overall completion rate for the task will be affected. A completion rate of 90% is the goal for each task in this usability test. | 1 - 4hr (Initial insertion to final withdrawal of the laparoscope) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance | The secondary outcome from the study will be an assessment of the performance of the FloShield 10mm Cannula and Oburator/FloShield System in its ability to defog and clean the laparoscopic lens. | 1 - 4hr (Initial insertion to final withdrawal of the laparoscope) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FloShield, MID, Minimally invasive surgery, Minimally Invasive devices, Robot-assisted Laparoscopic Surgery, Single-site Laparoscopic Surgery, Single Incision Laparoscopic Surgery, Cannula, Blunt Obturator, Cholecystectomy, Benign hysterectomy, Salpingo-oophorectomy