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New Use of the ViKY Device for Uterus Positioning

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

Tracking Information
First Submitted Date  ICMJE January 31, 2012
First Posted Date  ICMJE February 13, 2012
Last Update Posted Date December 28, 2012
Study Start Date  ICMJE December 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
  • Effectiveness [ Time Frame: 4 months ]
    Number of cases with adequate visualization of pelvic anatomy during endoscopy.
  • Adverse Events [ Time Frame: 4 months ]
    Number of perforations during intervention. Number of complications associated with the use of uterine manipulator
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 10, 2012)
surgery characterization [ Time Frame: 4 months ]
Duration of time of each procedure, duration of time to set up Viky UP device
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE New Use of the ViKY Device for Uterus Positioning
Official Title  ICMJE Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
Brief Summary Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Surgical Procedure, Unspecified
Intervention  ICMJE Device: ViKY UP
laparoscopic-assisted hysterectomy procedure
Study Arms  ICMJE Hysterectomy
candidate for a conventional laparoscopic-assisted
Intervention: Device: ViKY UP
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 10, 2012)
30
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01531504
Other Study ID Numbers  ICMJE ViKY UP IDE
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EndoControl
Study Sponsor  ICMJE EndoControl
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Arnold ADVINCULA, MD Floridal Hospital
Principal Investigator: Kevin STEPP, MD Carolinas Medical Center
PRS Account EndoControl
Verification Date December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP