Clinical trial NCT01531504: New Use of the ViKY Device for Uterus Positioning
Official title: Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgical Procedure, Unspecified
Keywords: hysterectomies
uterine manipulator
Lead sponsor: EndoControl
Sponsor class: INDUSTRY
First posted: 2012-02-13
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Effectiveness
timeFrame: 4 months
measure: Adverse Events
timeFrame: 4 months
Secondary outcomes:
measure: surgery characterization
timeFrame: 4 months
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
Study officials:
affiliation: Floridal Hospital
name: Arnold ADVINCULA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carolinas Medical Center
name: Kevin STEPP, MD
role: PRINCIPAL_INVESTIGATOR
References: