New Use of the ViKY Device for Uterus Positioning
Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning|
- Effectiveness [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Number of cases with adequate visualization of pelvic anatomy during endoscopy.
- Adverse Events [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]Number of perforations during intervention. Number of complications associated with the use of uterine manipulator
- surgery characterization [ Time Frame: 4 months ] [ Designated as safety issue: No ]Duration of time of each procedure, duration of time to set up Viky UP device
|Study Start Date:||December 2011|
|Study Completion Date:||September 2012|
|Primary Completion Date:||August 2012 (Final data collection date for primary outcome measure)|
candidate for a conventional laparoscopic-assisted
Device: ViKY UP
laparoscopic-assisted hysterectomy procedure
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01531504
|United States, Florida|
|Orlando, Florida, United States, 32804|
|United States, North Carolina|
|Carolinas Medical Center|
|Charlotte, North Carolina, United States, 28203|
|Principal Investigator:||Arnold ADVINCULA, MD||Floridal Hospital|
|Principal Investigator:||Kevin STEPP, MD||Carolinas Medical Center|