New Use of the ViKY Device for Uterus Positioning

EndoControl

Status: Completed

Conditions: Surgical Procedure, Unspecified

Treatments: Device: ViKY UP

Study type: Interventional

Funder types: Industry

Identifiers

NCT01531504

ViKY UP IDE

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hysterectomy

Other group

Description:

candidate for a conventional laparoscopic-assisted

Treatment:

Device: ViKY UP