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

Minimally Invasive Devices, Inc.20 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cholecystectomy Benign Hysterectomy Salingo-oophorectomy

Interventions

Cannula and Blunt ObturatorDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Baptist Health South Florida

Miami, Florida, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)

Secondary Outcomes

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.

Time frame: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)

Data from ClinicalTrials.gov

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