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New Use of the ViKY Device for Uterus Positioning

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ClinicalTrials.gov Identifier: NCT01531504
Recruitment Status : Completed
First Posted : February 13, 2012
Last Update Posted : December 28, 2012
Sponsor:
Information provided by (Responsible Party):
EndoControl

Brief Summary:
Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites

Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Device: ViKY UP Not Applicable

Detailed Description:

The ViKY device "Vision Control for endoscopy" was initially a compact motorized endoscope holder for laparoscopic surgery. It holds the endoscope and is controlled by either a foot pedal or voice activation. It received FDA approval in December 2008 and since that time has been used to facilitate laparoscopic surgery in multiple specialties.

EndoControl now considers using the technology for uterus manipulation in laparoscopic-assisted hysterectomies. Most gynecologic surgeries require displacement of the uterus out of the anatomic location to optimize the surgery. During an abdominal hysterectomy clamps are placed on the uterine cornua allowing easy manipulation of the uterus. The development of laparoscopic surgery required new techniques to manipulate the uterus. Typically a uterine manipulator is placed vaginally and controlled by the surgeon or the surgical assistant during the procedure.

In conventional operations, the constant physical force decreases the surgical team's efficacy and increases fatigue levels. The use of the ViKY device to control the position of the uterus facilitates surgery by enabling the surgeon to maintain a constant "locked" position or by allowing the surgeon to remotely move the uterus at any point of the surgery. The ViKY device also eliminates the need for an extra surgical assistant during laparoscopic-assisted hysterectomies.

The aim of this study is to collect data to demonstrate safety and effectiveness of the use of the ViKY device for uterine manipulation during conventional laparoscopic-assisted hysterectomies or computer-controlled laparoscopic hysterectomies.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
Study Start Date : December 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy

Arm Intervention/treatment
Hysterectomy
candidate for a conventional laparoscopic-assisted
Device: ViKY UP
laparoscopic-assisted hysterectomy procedure




Primary Outcome Measures :
  1. Effectiveness [ Time Frame: 4 months ]
    Number of cases with adequate visualization of pelvic anatomy during endoscopy.

  2. Adverse Events [ Time Frame: 4 months ]
    Number of perforations during intervention. Number of complications associated with the use of uterine manipulator


Secondary Outcome Measures :
  1. surgery characterization [ Time Frame: 4 months ]
    Duration of time of each procedure, duration of time to set up Viky UP device



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-80
  • Candidate for conventional laparoscopic-assisted hysterectomies procedures
  • patient has a cervix and a uterus

Exclusion criteria

  • Difficulty understanding the English language
  • Anatomy that precludes the use of a uterine manipulator
  • Current inclusion in another research study

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): NCT01531504


Locations
United States, Florida
Florida Hospital
Orlando, Florida, United States, 32804
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Sponsors and Collaborators
EndoControl
Investigators
Principal Investigator: Arnold ADVINCULA, MD Floridal Hospital
Principal Investigator: Kevin STEPP, MD Carolinas Medical Center

Responsible Party: EndoControl
ClinicalTrials.gov Identifier: NCT01531504     History of Changes
Other Study ID Numbers: ViKY UP IDE
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: December 28, 2012
Last Verified: December 2012

Keywords provided by EndoControl:
hysterectomies
uterine manipulator