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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02163239
Recruitment Status : Terminated (Not meeting primary objective of the study)
First Posted : June 13, 2014
Last Update Posted : September 28, 2015
Sponsor:
Information provided by (Responsible Party):
Minimally Invasive Devices, Inc.

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.

Condition or disease Intervention/treatment
Cholecystectomy Benign Hysterectomy Salingo-oophorectomy Device: Cannula and Blunt Obturator

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Study Type : Observational
Actual Enrollment : 20 participants
Time Perspective: Prospective
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
Study Start Date : March 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Group/Cohort Intervention/treatment
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
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
Other Names:
  • FloShield 10mm Endoscopic Cannula, FRT10C
  • FloShield Blunt Oburator, FRT10B




Primary Outcome Measures :
  1. Completion rate [ Time Frame: 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 Outcome Measures :
  1. Performance [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163239


Locations
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United States, Florida
Baptist Health South Florida
Miami, Florida, United States, 33183
Sponsors and Collaborators
Minimally Invasive Devices, Inc.
Investigators
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Study Director: Wayne Poll, MD Minimally Invasive Devices
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Responsible Party: Minimally Invasive Devices, Inc.
ClinicalTrials.gov Identifier: NCT02163239    
Other Study ID Numbers: FRT-0001
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: September 28, 2015
Last Verified: September 2015
Keywords provided by Minimally Invasive Devices, Inc.:
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