NCT03450421

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

A Randomized, Controlled, Multi-Center Study to Assess the Safety and Efficacy of Actamax™ Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery With a Myomectomy Followed by Second Look Laparoscopy (SLL)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Actamax Surgical Materials LLC · Industry
• Sex: Female
• Age: 18 Years – 44 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Actamax™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.

Timeline

• Start date: 2018-06-01
• Primary completion: 2019-11-01
• Completion: 2024-07-01
• First posted: 2018-03-01
• Last updated: 2018-03-01

Regulatory

• FDA-regulated device study