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

NCT02163239 | Terminated

• 1 other identifier: FRT-0001
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Cholecystectomy; Benign Hysterectomy; Salingo-oophorectomy

Keywords

FloShield; MID; Minimally invasive surgery; Minimally Invasive devices; Robot-assisted Laparoscopic Surgery; Single-site Laparoscopic Surgery; Single Incision Laparoscopic Surgery; Cannula; Blunt Obturator; Cholecystectomy; Benign hysterectomy; Salpingo-oophorectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Performance

  1 - 4hr (Initial insertion to final withdrawal of the laparoscope)

Study Arms (1)

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

Interventions

Cannula and Blunt Obturator DEVICE

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

Also known as: FloShield 10mm Endoscopic Cannula, FRT10C, FloShield Blunt Oburator, FRT10B

10mm Cannula

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• Minimally Invasive Devices, Inc.: lead

Study Sites (1)

Baptist Health South Florida

Miami, Florida, 33183, United States

Location

MeSH Terms

Interventions

Cannula

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Wayne Poll, MD

  Minimally Invasive Devices

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 13, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: September 28, 2015

Record last verified: 2015-09

Locations

US (1)