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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02163239

Enrollment

Registered

2014-06-13

Start date

2015-03-31

Completion date

2015-09-30

Last updated

2015-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Benign Hysterectomy, Cholecystectomy, 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

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.

Interventions

DEVICECannula 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

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Completion rate	1 - 4hr (Initial insertion to final withdrawal of the laparoscope)	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.

Secondary

Measure	Time frame	Description
Performance	1 - 4hr (Initial insertion to final withdrawal of the laparoscope)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026