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New Use of the ViKY Device for Uterus Positioning

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EndoControl
ClinicalTrials.gov Identifier:
NCT01531504
First received: January 31, 2012
Last updated: December 27, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention
Surgical Procedure, Unspecified
 Device: ViKY UP

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by EndoControl:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 30
Study Start Date: December 2011
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Hysterectomy
candidate for a conventional laparoscopic-assisted
 Device: ViKY UP
laparoscopic-assisted hysterectomy procedure

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: EndoControl
ClinicalTrials.gov Identifier: NCT01531504     History of Changes
Other Study ID Numbers: ViKY UP IDE
Study First Received: January 31, 2012
Last Updated: December 27, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by EndoControl:
hysterectomies
uterine manipulator

ClinicalTrials.gov processed this record on May 21, 2013