Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy

NCT03450421 | Unknown DMC FDA Device

• 1 other identifier: ABS-03UE-2014
• Study Type: interventional
• Target: 152
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Uterine Fibroid

Outcome Measures

Primary Outcomes (1)

• Adhesion Free at Sites of Surgery at SLL

  The primary efficacy outcome measure will be being adhesion free at sites of surgery throughout the whole abdominopelvic cavity at SLL.

  8-12 weeks postoperatively but out to 16 weeks where circumstances require (vacations, etc.)

Study Arms (2)

Actamax™Adhesion Barrier

EXPERIMENTAL

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).

Device: Actamax™Adhesion Barrier

Surgical Control

NO INTERVENTION

Myomectomy will be performed with no adhesion barrier application.

Interventions

Actamax™Adhesion Barrier DEVICE

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.

Actamax™Adhesion Barrier

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• The subject underwent a laparoscopic myomectomy with at least (1) posterior uterine serosal incision of \> 3 cm in length,

You may not qualify if:

• 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.
• 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,

Sponsors & Collaborators

• Actamax Surgical Materials LLC: lead

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Trudy Estridge

  Actamax Surgical Materials LLC

  STUDY DIRECTOR

Central Study Contacts

Trudy D Estridge, PhD

CONTACT

650-245-6561; trudy.estridge@actamax.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2018
• First Posted: March 1, 2018
• Study Start: June 1, 2018
• Primary Completion: November 1, 2019
• Study Completion: July 1, 2024
• Last Updated: March 1, 2018

Record last verified: 2018-02