NCT02163239

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 20 (actual)
• Sponsor: Minimally Invasive Devices, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cholecystectomy
• Benign Hysterectomy
• Salingo-oophorectomy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2015-03-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2014-06-13
• Last updated: 2015-09-28

Locations

1 site across 1 country: United States