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

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).

Study Overview

• Status: Completed
• Conditions: Pelvic Organ Prolapse

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 the placement of the VFIX device by using the routine operating room instrument to push the top of your vagina towards the ligament.

• Study Type: Observational
• Enrollment (Actual): 49

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • North Shore Private Hospital
    • Sydney, New South Wales, Australia
      • St George Private Hospital
  • Victoria
    • Melbourne, Victoria, Australia
      • Frances Perry House
    • Melbourne, Victoria, Australia
      • Royal Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

hospital referrals

Description

Inclusion Criteria:

• 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 Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Ethicon, Inc.

Study record dates

Study Major Dates

• Study Start: July 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: August 25, 2009
• First Submitted That Met QC Criteria: August 25, 2009
• First Posted (Estimate): August 26, 2009

Study Record Updates

• Last Update Posted (Estimate): February 10, 2010
• Last Update Submitted That Met QC Criteria: February 9, 2010
• Last Verified: February 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Prolapse; Pelvic Organ Prolapse
• Other Study ID Numbers: 300-08-009