a Study to Evaluate Adhesion Risk in Fertility Patients' Status Post Laparoscopic Myomectomy.

This is a post-market, controlled, single-center study to evaluate V-Loc suture. 10
subjects will be included in this study. Premenopausal women ages 18-42 will undergo a
laparoscopic myomectomy. Adhesion scoring will be done prior to the myomectomy using a
modified American Fertility Society scoring technique. V-loc 180 suture will be utilized in
all patients for closure of all uterine defects. All patients will then be evaluated by
means of a second look laparoscopy (SLL) 6-12 weeks after the initial surgery and evaluated
via modified American Fertility Society scoring techniques.

An independent reviewer will also score adhesions utilizing video recordings made from the
second look laparoscopic surgery , using the same scoring techniques employed by the PI..

Patients will undergo routine preoperative blood tests in accordance with the Primary
Investigators' usual standard of practice. All patients who meet the inclusion criteria will
be considered. Patients will be consented prior to entry into the operating room. Surgical
time will be measured from start of procedure, start of myomectomy, and start and finish
time of each individual uterine closure. All investigators will provide usual and customary
care to research subjects during the first look laparoscopy. This includes the use of all
standard practice anti-adhesive agents and heparinized irrigation fluids

. Physicians will be surveyed on ease of use and any problems that occur with V-Loc suture.

All patients will be treated with post-operative antibiotics per the Primary Investigator's
usual standard of care. Patients will be contacted both one and 4 weeks post surgery and
evaluated for complications using a phone survey for pain and bowel functioning. The patient
will also have a standard post operative exam with the physician 4-6 weeks post-operatively.
A second look laparoscopy will be performed 6-12 weeks following the initial myomectomy.
Adhesions will be evaluated using a modified American Fertility Society evaluation tool. Any
adhesions seen at the time of SLL will be treated using the physician's preferred method of
adhesiolysis. A recording will be obtained of the second look laparoscopy and will be
reviewed and scored by an independent reviewer as to the level of adhesions seen .

Inclusion Criteria:

Premenopausal female ages 18-42 At least one fibroid 3 cm or greater requiring at least
one uterine incision Preparing to undergo Laparoscopic myomectomy

Exclusion Criteria:

Post-menopausal or Pregnant

- Endometriosis involving the uterus

- Adhesions to the uterus found at the time of initial laparoscopy

- History of /Current cancer , except basal cell

- Surgery Contraindications, including cardiac or other major system issue

- Greater than 5 fibroids

- The patient has ever been treated with uterine artery embolization of the myoma
or magnetic resonance imaging (MRI) or other guided
ultrasonification of myoma(s).

- The patient has any medical condition that might interfere with the safety of
surgery and the second look laparoscopy, such as active intra-abdominal infection or
abscess

- BMI > 34