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

Terminated

• Conditions: Salingo-oophorectomy; Benign Hysterectomy; Cholecystectomy
• Interventions: Device: Cannula and Blunt Obturator

• Registration Number: NCT02163239
• Lead Sponsor: Minimally Invasive Devices, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-10
• Study First Submitted QC: 2014-06-11
• Study First Posted: 2014-06-13
• Study Start: 2015-03
• Status Verified: 2015-09
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2015-09-25
• Last Update Posted: 2015-09-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
10mm Cannula	Cannula and Blunt Obturator	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

Primary Outcome Measures

Name	Time	Method
Completion rate	1 - 4hr (Initial insertion to final withdrawal of the laparoscope)	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.

Secondary Outcome Measures

Name	Time	Method
Performance	1 - 4hr (Initial insertion to final withdrawal of the laparoscope)	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.

Trial Locations

Locations (1)

Baptist Health South Florida; 🇺🇸 Miami, Florida, United States