Surgical Procedure, UnspecifiedNCT01531504
New Use of the ViKY Device for Uterus Positioning
A study testing ViKY UP in people with Surgical Procedure, Unspecified, run by EndoControl at 2 sites in United States.
Trial summary
Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Surgical Procedure, Unspecified
- What is being tested?
- ViKY UP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2011to Sep 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80
- Candidate for conventional laparoscopic-assisted hysterectomies procedures
- patient has a cervix and a uterus
Who cannot join
- Difficulty understanding the English language
- Anatomy that precludes the use of a uterine manipulator
- Current inclusion in another research study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carolinas Medical Center
Charlotte, North Carolina, 28203
Florida Hospital
Orlando, Florida, 32804
About this study
Official title: Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
Evaluation of Safety and Efficacy of ViKY Device for Uterus Positioning on 2 US sites
Read the 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.
- Conditions
- Surgical Procedure, Unspecified
- Being tested
- ViKY UP
- Keywords
- hysterectomies, uterine manipulator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ViKY UPDevice
laparoscopic-assisted hysterectomy procedure
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy | Other | candidate for a conventional laparoscopic-assisted Receives: Device: ViKY UP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness
Number of cases with adequate visualization of pelvic anatomy during endoscopy.
Measured: 4 months
Adverse Events
Number of perforations during intervention. Number of complications associated with the use of uterine manipulator
Measured: 4 months
Secondary outcomes (1)
surgery characterization
Duration of time of each procedure, duration of time to set up Viky UP device
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startDec 2011
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgical Procedure, UnspecifiedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- EndoControl
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arnold ADVINCULA, MD, Principal investigator, Floridal HospitalKevin STEPP, MD, Principal investigator, Carolinas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531504
- Sponsor's protocol ID
- ViKY UP IDE
- Status last verified
- Dec 2012
- First submitted
- 31 Jan 2012
- Last updated
- 28 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Effectiveness of ViKY Device for Uterine Positioning
- ClinicalTrials.gov ID
- NCT01531504
- Acronym / sponsor ID
- ViKY UP IDE
- Conditions
- Surgical Procedure, Unspecified
- Keywords
- hysterectomies, uterine manipulator
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EndoControlIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 13 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy | Other | Device: ViKY UPcandidate for a conventional laparoscopic-assisted |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-80
- Candidate for conventional laparoscopic-assisted hysterectomies procedures
- patient has a cervix and a uterus
Key exclusion criteria (3 listed)
- Difficulty understanding the English language
- Anatomy that precludes the use of a uterine manipulator
- Current inclusion in another research study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ViKY UPlaparoscopic-assisted hysterectomy procedure | Device | Hysterectomy |
Primary outcome
Effectiveness
Time frame: 4 months
Number of cases with adequate visualization of pelvic anatomy during endoscopy.
Adverse Events
Time frame: 4 months
Number of perforations during intervention. Number of complications associated with the use of uterine manipulator
1 secondary outcome
surgery characterization
Time frame: 4 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arnold ADVINCULA, MD principal investigator
Floridal Hospital
Kevin STEPP, MD principal investigator
Carolinas Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ViKY UP in people with Surgical Procedure, Unspecified, run by EndoControl at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2012.