Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
Uterine Fibroid
About this trial
This is an interventional treatment trial for Uterine Fibroid
Eligibility Criteria
Preoperative Inclusion Criteria:
- Understand and be able to follow the requirements of the protocol including personally signing and dating an IRB approved Informed Consent Form prior to undergoing any protocol related procedures,
- Be a premenopausal female, > 18 and < 44 years old,
- Be thought to have uterine fibroids requiring laparoscopic abdominopelvic surgery that will require a > 3 cm posterior uterine incision (including repeat myomectomy/previous uterine artery embolization for fibroid), and/or +/- adhesions, and/or +/- endometriosis, and/or +/- adenomyosis and/or ovarian cyst(s),
- Wish to retain her fertility and be considered to clinically benefit from a SLL, in the investigator's opinion,
- Have a willingness to undergo a second look laparoscopy if surgeon considers it clinically beneficial to the subject,
- Have a negative pregnancy test within 5 days of surgery,
- Agree to avoid pregnancy using adequate forms of contraception (oral contraceptive pill, condom, no sexual intercourse), and is aware and agrees to avoid pregnancy for a minimum of 12 weeks or to SLL (whichever is greater) to allow for healing of the uterine scar following myomectomy,
- Is willing, able and likely to fully comply with study procedures and restrictions including follow-up,
- Be in good health including an ASA (American Society of Anesthesiologists) score of 2 or less,
- Have undergone a satisfactory physical and medical assessment with no clinically significant and relevant abnormalities.
Intraoperative Inclusion Criteria:
- The subject underwent a laparoscopic myomectomy with at least (1) posterior uterine serosal incision of > 3 cm in length,
- The subject meets all intraoperative inclusion/exclusion criteria prior to randomization,
And
• At the completion of the procedure, before randomization, the surgeon believes that the subject will clinically benefit from a second look laparoscopy to preserve fertility.
Preoperative Exclusion Criteria:
- Are unable to give their own written informed consent,
- Have completed her family planning with no desire to maintain fertility,
- Are considered to have no potential clinical benefit from a second look laparoscopy,
- Are currently pregnant (including ectopic pregnancy),
- Are breastfeeding,
- Are within 6 weeks post-partum,
- Have received or are expected to receive another anti-adhesive treatment within 30 days prior to enrollment or during enrollment up to adhesion evaluation at second look laparoscopy,
- Are currently or have been enrolled within the last 30 days in another interventional study.
- Have received or are expected to receive any other investigational product or technique within 30 days prior to or during enrollment,
- Have had cancer within 5 years of the initial surgery with the exception of basal cell carcinoma,
- Have known allergy to dextran, PEG, or FD&C Blue #1,
- Have had bilateral salpingectomy,
- Have had a hysterectomy,
- Are scheduled to undergo concomitant non-gynecologic surgery,
- Have pre-operative imaging results with:
- Largest fibroid diameter < 2 cm, or
- Largest intramural fibroid diameter >10 cm, or
- More than 5 intramural fibroids with a diameter of > 8 cm, and/or
- Adenomyoma >10 cm.
- Have a history where it is expected that complete adhesiolysis will be impossible,
- Have clinically significant abnormal blood results,
- Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, hematological or coagulation disorders,
- Have insulin dependent diabetes mellitus,
- Are receiving concurrent systemic corticosteroids, antineoplastic agents and/or radiation therapy,
- Have had previous abdominal or pelvic radiation therapy,
- Have active pelvic or abdominal infection, or other active infection with fever >100°F/38°C,
- Have a known history of methicillin-resistant Staphylococcus aureus (MRSA), HIV, HBV or HCV.
Intraoperative Exclusion Criteria:
- Have cancer detected at surgery,
- Are pregnant, including ectopic pregnancy,
- Have a non-gynecologic surgical procedure or entry into the bowel, bladder, or ureter,
- Have a hysterectomy or other gynecologic procedure that would render the subject unable to conceive,
- Have incomplete lysis of any pre-existing pathological adhesions,
- Have extensive enterolysis,
- Have incomplete surgical treatment of endometriosis,
- Receive the administration of a product that will interfere with the application of Actamax™ Adhesion Barrier,
- Receive the use of an approved or unapproved product or strategy for the purpose of preventing adhesion development,
- Receive fibrin glue, surgical sealant, or other hemostatic agent,
- Undergo an open procedure (other than mini laparotomy to remove fibroids),
- Undergo a posterior colpotomy,
- Undergo insufflation with a gas other than CO2,
- Undergo Laprolift or similar device for elevation of the abdominal wall, as an alternative to CO2 insufflation,
- Undergo abdominal cavity heating, humidification or oxygenation,
- Receive irrigants containing, glucocorticoids, antihistamines, heparin or antiseptic additives,
- Have any instillates left at the end of surgery,
- Have a postoperative drain,
- Undergo laparoscopic myomectomy without at least one posterior uterine serosal incision of > 3 cm in length,
Undergo a diagnostic hysteroscopy or polypectomy or therapeutic hysteroscopy which includes any of the following:
- Undertaken during or following the laparoscopic myomectomy,
- Treatment of fibroids >3 cm,
- Solution other than Lactated Ringer's Solution (LRS) used for uterine distention,
- Laparoscopic filming commenced after removal of LRS.
- If, in the opinion of the surgeon, subject would have no clinical benefit for a SLL.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Actamax™Adhesion Barrier
Surgical Control
Following Myomectomy, subjects randomized to the Actamax™Adhesion Barrier Arm will have up to 30mL of product applied to all sites of surgery (area of treatment/trauma).
Myomectomy will be performed with no adhesion barrier application.