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

Stopped early

Conditions studied: Cholecystectomy, Benign Hysterectomy, Salingo-oophorectomy

In brief

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.

Key facts

Study ID

NCT02163239

Run by

Minimally Invasive Devices, Inc.

People needed

20

Starts

2015-03-01

Expected to finish

2015-09-01

Last updated by the study team

2015-09-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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