Uterine Fibroid
Conditions
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-existing pathology e.g. (+/-) adhesions and/or (+/-) endometriosis, and/or (+/-) adenomyosis, and/or (+/-) ovarian cyst(s). The value of the second look laparoscopy (SLL) must be confirmed by the investigator to be of clinical benefit to the subject. The subject must be desirous of future fertility and willing to undergo the SLL to assess whether pathology (e.g. adnexal adhesions or endometriosis) exists which could be treated with a goal of improving their likelihood of conceiving and progressing to full term.
Interventions
DEVICEActamax™Adhesion Barrier
Actamax™Adhesion Barrier is a degradable hydrogel to be sprayed directly on surgically traumatized tissue. The aim of using the Actamax™ Adhesion Barrier (AB) in this way is to allow damaged and apposing tissue surfaces the opportunity to heal separately without becoming abnormally attached.
Sponsors
Actamax Surgical Materials LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adhesion Free at Sites of Surgery at SLL | 8-12 weeks postoperatively but out to 16 weeks where circumstances require (vacations, etc.) | The primary efficacy outcome measure will be being adhesion free at sites of surgery throughout the whole abdominopelvic cavity at SLL. |
Contacts
Primary ContactTrudy D Estridge, PhD
Outcome results
None listed