New Use of the ViKY Device for Uterus Positioning

Not Applicable

Completed

• Conditions: Surgical Procedure, Unspecified
• Interventions: Device: ViKY UP

• Registration Number: NCT01531504
• Lead Sponsor: EndoControl

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 Timeline

• Study Start: 2011-12
• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-10
• Study First Posted: 2012-02-13
• Primary Completion: 2012-08
• Study Completion: 2012-09
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-27
• Last Update Posted: 2012-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hysterectomy	ViKY UP	candidate for a conventional laparoscopic-assisted

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
surgery characterization	4 months	Duration of time of each procedure, duration of time to set up Viky UP device

Trial Locations

Locations (2)

Florida Hospital; 🇺🇸 Orlando, Florida, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States