Status:
UNKNOWN
Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
Lead Sponsor:
Actamax Surgical Materials LLC
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
18-44 years
Phase:
NA
Brief Summary
Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-...
Eligibility Criteria
Inclusion
- Preoperative
- 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
- 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
- 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
Key Trial Info
Start Date :
June 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2024
Estimated Enrollment :
152 Patients enrolled
Trial Details
Trial ID
NCT03450421
Start Date
June 1 2018
End Date
July 1 2024
Last Update
March 1 2018
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.