Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | 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 |
| Measure | Description | 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
hospital referrals
Not provided
| Name | Affiliation | Role |
|---|---|---|
| David Robinson, MD | Ethicon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North Shore Private Hospital | Sydney | New South Wales | Australia | |||
| St George Private Hospital |
Not provided
| ID | Term |
|---|---|
| D056887 | Pelvic Organ Prolapse |
| ID | Term |
|---|---|
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
| Intraoperative |
| Sydney |
| New South Wales |
| Australia |
| Frances Perry House | Melbourne | Victoria | Australia |
| Royal Women's Hospital | Melbourne | Victoria | Australia |