MedDataX Logo

New Use of the ViKY Device for Uterus Positioning

NCT ID: NCT01531504

Last Updated: 2012-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2012-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgical Procedure, Unspecified

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

hysterectomies uterine manipulator

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Hysterectomy

candidate for a conventional laparoscopic-assisted

Group Type OTHER

ViKY UP

Intervention Type DEVICE

laparoscopic-assisted hysterectomy procedure

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ViKY UP

laparoscopic-assisted hysterectomy procedure

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

EndoControl

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arnold ADVINCULA, MD

Role: PRINCIPAL_INVESTIGATOR

Floridal Hospital

Kevin STEPP, MD

Role: PRINCIPAL_INVESTIGATOR

Carolinas Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Florida Hospital

Orlando, Florida, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

ViKY UP IDE

Identifier Type: -

Identifier Source: org_study_id