Clinical trial NCT00965952: A Surgical Simulation Study to Evaluate the Safety of a Device Mechanism as Treatment for Vaginal Apical Prolapse
Official title: A Prospective, Observational Surgical Simulation Study to Evaluate the Safety of the VFIX Device Mechanism as Treatment for Vaginal Apical Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Organ Prolapse
Lead sponsor: Ethicon, Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-26
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospital referrals

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Intraoperative
Secondary outcomes:
measure: 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
timeFrame: Intraoperative
measure: 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
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: North Shore Private Hospital
state: New South Wales
city: Sydney
country: Australia
facility: St George Private Hospital
state: New South Wales
city: Melbourne
country: Australia
facility: Frances Perry House
state: Victoria
city: Melbourne
country: Australia
facility: Royal Women's Hospital
state: Victoria
Study officials:
affiliation: Ethicon, Inc.
name: David Robinson, MD
role: STUDY_DIRECTOR
References: