New Use of the ViKY Device for Uterus Positioning

Surgical Procedure, Unspecified Clinical Trial

Official title:

Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01531504
• Other study ID #: ViKY UP IDE
• Status: Completed
• Phase: N/A
• First received: January 31, 2012
• Last updated: December 27, 2012
• Start date: December 2011
• Est. completion date: September 2012

Study information

• Verified date: December 2012
• Source: EndoControl
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Device:
• ViKY UP
laparoscopic-assisted hysterectomy procedure

Locations

Country	Name	City	State
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Florida Hospital	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
EndoControl

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effectiveness	Number of cases with adequate visualization of pelvic anatomy during endoscopy.	4 months
Primary	Adverse Events	Number of perforations during intervention. Number of complications associated with the use of uterine manipulator	4 months
Secondary	surgery characterization	Duration of time of each procedure, duration of time to set up Viky UP device	4 months