NCT01531504

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

December 28, 2012

Status Verified

December 1, 2012

Enrollment Period

8 months

First QC Date

January 31, 2012

Last Update Submit

December 27, 2012

Conditions

Surgical Procedure, Unspecified

Keywords

hysterectomiesuterine manipulator

Outcome Measures

Primary Outcomes (2)

  • Effectiveness

    Number of cases with adequate visualization of pelvic anatomy during endoscopy.

    4 months

  • Adverse Events

    Number of perforations during intervention. Number of complications associated with the use of uterine manipulator

    4 months

Secondary Outcomes (1)

  • surgery characterization

    4 months

Study Arms (1)

Hysterectomy

OTHER

candidate for a conventional laparoscopic-assisted

Device: ViKY UP

Interventions

ViKY UPDEVICE

laparoscopic-assisted hysterectomy procedure

Hysterectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-80
  • Candidate for conventional laparoscopic-assisted hysterectomies procedures
  • patient has a cervix and a uterus

You may not qualify if:

  • Difficulty understanding the English language
  • Anatomy that precludes the use of a uterine manipulator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Florida Hospital

Orlando, Florida, 32804, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28203, United States

Location

Study Officials

  • Arnold ADVINCULA, MD

    Floridal Hospital

    PRINCIPAL INVESTIGATOR

  • Kevin STEPP, MD

    Carolinas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 13, 2012

Study Start

December 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

December 28, 2012

Record last verified: 2012-12

Locations

US(2)