Status:
COMPLETED
A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
Lead Sponsor:
Ethicon, Inc.
Conditions:
Pelvic Organ Prolapse
Eligibility:
FEMALE
18+ years
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).
Detailed Description
In this study, the surgeon will not use the actual V-Fix device. Instead, the surgeon will use a routine operating room instrument, which is similar to the size and shape of the V-Fix device to mimic ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- None
Key Trial Info
Start Date :
July 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00965952
Start Date
July 1 2009
End Date
December 1 2009
Last Update
February 10 2010
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
North Shore Private Hospital
Sydney, New South Wales, Australia
2
St George Private Hospital
Sydney, New South Wales, Australia
3
Frances Perry House
Melbourne, Victoria, Australia
4
Royal Women's Hospital
Melbourne, Victoria, Australia