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

Uterine Fibroid Clinical Trial

Official title:
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)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03450421
Study type Interventional
Source Actamax Surgical Materials LLC
Contact Trudy D Estridge, PhD
Phone 650-245-6561
Email trudy.estridge@actamax.com
Status Not yet recruiting
Phase N/A
Start date June 2018
Completion date July 2024
View Details
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