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

Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02163239
• Other study ID #: FRT-0001
• Status: Terminated
• Phase: N/A
• First received: June 10, 2014
• Last updated: September 25, 2015
• Start date: March 2015
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: Minimally Invasive Devices, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Hysterectomy
• Cholecystectomy
• Salingo-oophorectomy

Intervention

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

Locations

Country	Name	City	State
United States	Baptist Health South Florida	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Minimally Invasive Devices, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	Performance	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.	1 - 4hr (Initial insertion to final withdrawal of the laparoscope)	No