A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse

Completed

• Conditions: Pelvic Organ Prolapse

• Registration Number: NCT00965952
• Lead Sponsor: Ethicon, Inc.

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

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-25
• Study First Submitted QC: 2009-08-25
• Study First Posted: 2009-08-26
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-09
• Last Update Posted: 2010-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (4)

Royal Women's Hospital; 🇦🇺 Melbourne, Victoria, Australia

North Shore Private Hospital; 🇦🇺 Sydney, New South Wales, Australia

St George Private Hospital; 🇦🇺 Sydney, New South Wales, Australia

Frances Perry House; 🇦🇺 Melbourne, Victoria, Australia