New Use of the ViKY Device for Uterus Positioning

Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning

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

Study Overview

• Status: Completed
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Device: ViKY UP

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: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32804
      • Florida Hospital
  • North Carolina
    • Charlotte, North Carolina, United States, 28203
      • Carolinas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hysterectomy; candidate for a conventional laparoscopic-assisted	Device: ViKY UP; laparoscopic-assisted hysterectomy procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness	Number of cases with adequate visualization of pelvic anatomy during endoscopy.	4 months
Adverse Events	Number of perforations during intervention. Number of complications associated with the use of uterine manipulator	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
surgery characterization	Duration of time of each procedure, duration of time to set up Viky UP device	4 months

Collaborators and Investigators

• Sponsor: EndoControl
• Investigators: Principal Investigator: Arnold ADVINCULA, MD, Floridal Hospital; Principal Investigator: Kevin STEPP, MD, Carolinas Medical Center

Study record dates

Study Major Dates

• Study Start: December 1, 2011
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: January 31, 2012
• First Submitted That Met QC Criteria: February 10, 2012
• First Posted (Estimate): February 13, 2012

Study Record Updates

• Last Update Posted (Estimate): December 28, 2012
• Last Update Submitted That Met QC Criteria: December 27, 2012
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: hysterectomies; uterine manipulator
• Other Study ID Numbers: ViKY UP IDE