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

Minimally Invasive Devices, Inc.

Status: Terminated

Conditions: Salingo-oophorectomy; Cholecystectomy; Benign Hysterectomy

Treatments: Device: Cannula and Blunt Obturator

Study type: Observational

Funder types: Industry

Identifiers

NCT02163239

FRT-0001

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 1 patient group

10mm Cannula

Description:

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

Treatment:

Device: Cannula and Blunt Obturator