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

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

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 Overview

• Status: Terminated
• Conditions: Cholecystectomy; Benign Hysterectomy; Salingo-oophorectomy
• Intervention / Treatment: Device: Cannula and Blunt Obturator

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33183
      • Baptist Health South Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects will be recruited from a population of patients who are from the medical practice of the study investigator and who are scheduled to undergo robot-assisted laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy

Description

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

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
10mm Cannula; 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; 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; Other Names: FloShield 10mm Endoscopic Cannula, FRT10C; FloShield Blunt Oburator, FRT10B

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Minimally Invasive Devices, Inc.
• Investigators: Study Director: Wayne Poll, MD, Minimally Invasive Devices

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Estimate): September 28, 2015
• Last Update Submitted That Met QC Criteria: September 25, 2015
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Cholecystectomy; FloShield; MID; Minimally invasive surgery; Minimally Invasive devices; Robot-assisted Laparoscopic Surgery; Single-site Laparoscopic Surgery; Single Incision Laparoscopic Surgery; Cannula; Blunt Obturator; Benign hysterectomy; Salpingo-oophorectomy
• Other Study ID Numbers: FRT-0001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No