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).
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
49
North Shore Private Hospital
Sydney, New South Wales, Australia
St George Private Hospital
Sydney, New South Wales, Australia
Frances Perry House
Melbourne, Victoria, Australia
Royal Women's Hospital
Melbourne, Victoria, Australia
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
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
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
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