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Completed

NCT Number: NCT01531504

New Use of the ViKY Device for Uterus Positioning

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

Completed

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Florida Hospital, Orlando, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ViKY UP

Device

laparoscopic-assisted hysterectomy procedure

Primary outcomes

  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 outcomes

  1. surgery characterization

    Time frame: 4 months

    Duration of time of each procedure, duration of time to set up Viky UP device

Sponsors and collaborators

Lead sponsor

EndoControl

Industry

Registry information

Official study title

Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Feb 13, 2012
Registry last updated
Dec 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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