An interventional study of ViKY UP in Surgical Procedure, Unspecified, sponsored by EndoControl. Completed at 2 sites in United States. Open to female participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2012-12-28.
Sponsored by EndoControl · Not applicable, Interventional, and Treatment
Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites
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.
This is the only study on the registry with EndoControl as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
candidate for a conventional laparoscopic-assisted
Device: ViKY UP
laparoscopic-assisted hysterectomy procedure
Effectiveness
Number of cases with adequate visualization of pelvic anatomy during endoscopy.
Time frame: 4 months
Adverse Events
Number of perforations during intervention. Number of complications associated with the use of uterine manipulator
Time frame: 4 months
surgery characterization
Duration of time of each procedure, duration of time to set up Viky UP device
Time frame: 4 months
This study is completed, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.