Text Size

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

This study has been completed.
Sponsor:
Information provided by:
Ethicon, Inc.
ClinicalTrials.gov Identifier:
NCT00965952
First received: August 25, 2009
Last updated: February 9, 2010
Last verified: February 2010
History of Changes
  Purpose

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).


Condition
Pelvic Organ Prolapse

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Ethicon, Inc.:

Primary Outcome Measures:
  • 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 [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]
  • 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 [ Time Frame: Intraoperative ] [ Designated as safety issue: Yes ]

Enrollment: 49
Study Start Date: July 2009
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

hospital referrals

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00965952

Locations
Australia, New South Wales
North Shore Private Hospital
Sydney, New South Wales, Australia
St George Private Hospital
Sydney, New South Wales, Australia
Australia, Victoria
Royal Women's Hospital
Melbourne, Victoria, Australia
Frances Perry House
Melbourne, Victoria, Australia
Sponsors and Collaborators
Ethicon, Inc.
Investigators
Study Director: David Robinson, MD Ethicon, Inc.
  More Information

No publications provided

Responsible Party: David Robinson MD/Medical Director, Ethicon
ClinicalTrials.gov Identifier: NCT00965952     History of Changes
Other Study ID Numbers: 300-08-009
Study First Received: August 25, 2009
Last Updated: February 9, 2010
Health Authority: Australia: Human Research Ethics Committee

Additional relevant MeSH terms:
Prolapse
Pelvic Organ Prolapse
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 19, 2013