A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse
1 other identifier
observational
49
1 country
4
Brief Summary
The purpose of this pilot study is to perform a procedure to evaluate the safety of the placement of a new device (known as the VFIX device).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2009
Shorter than P25 for all trials
4 active sites
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
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 25, 2009
CompletedFirst Posted
Study publicly available on registry
August 26, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedFebruary 10, 2010
February 1, 2010
5 months
August 25, 2009
February 9, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of subjects without any bowel entrapment between the vagina and the right SSL in subjects that the surgeon declares he would have deployed the V-Fix device
Intraoperative
Secondary Outcomes (2)
Incidence of subjects without any bladder entrapment or traversing of the peritoneal cavity between the vagina and the right or left SSL in subjects that the surgeon declares he would have deployed the V-Fix device
Intraoperative
Incidence of subjects without any bowel entrapment between the vagina and the left SSL in subjects that the surgeon declares he would have deployed the V-Fix device
Intraoperative
Eligibility Criteria
hospital referrals
You may qualify if:
- Age greater than or equal to 18 years.
- Subjects with apical support prolapse in whom the surgeon may consider a surgical procedure to correct level 1 support, with "C" or "D" descent at least halfway down the vaginal length (i.e. uterus and cervix or the vaginal vault in hysterectomised subjects), and having laparoscopy or abdominal surgery (additional surgery e.g. tubal ligation or ovarian cystectomy is also allowed).
- Vaginal examination during the screening visit confirms that the lateral fornix of the vagina can reach both the left and right SSL and therefore the surgical simulation can be performed.
- The investigator considers that the subject is medically fit enough to receive extended anaesthesia of approximately 15 minutes, to complete the additional anatomical observation study procedures.
- Subjects agree to participate in the study and document this agreement by signing the Ethics Committee approved informed consent.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ethicon, Inc.lead
Study Sites (4)
North Shore Private Hospital
Sydney, New South Wales, Australia
St George Private Hospital
Sydney, New South Wales, Australia
Frances Perry House
Melbourne, Victoria, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
David Robinson, MD
Ethicon, Inc.
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2009
First Posted
August 26, 2009
Study Start
July 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
February 10, 2010
Record last verified: 2010-02