NCT01750008

Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions

The LUSTOR (Laparoscopic Uterine Sparing Techniques Outcomes and Reinterventions)Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Acessa Health, Inc. · Industry
• Sex: Female
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to compare the outcomes of two uterine-conserving treatment alternatives for symptomatic uterine fibroids: laparoscopic myomectomy (LM) and global fibroid ablation (GFA) using the Halt System. Laparoscopic ultrasound (LUS) is a standard step prior to the GFA procedure but has not been a standard step prior to LM. Incorporating laparoscopic ultrasound as a first step prior to both treatments allows the surgeon to have equal access to valuable imaging information and to plan treatment accordingly. By randomizing the subject immediately after laparoscopic ultrasound, selection bias toward one treatment or the other following the LUS is eliminated.

Conditions

• Uterine Fibroids
• Myomas

Interventions

Type	Name	Description
PROCEDURE	Global Fibroid Ablation
PROCEDURE	Myomectomy

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-09-01
• Completion: 2018-06-01
• First posted: 2012-12-17
• Last updated: 2018-11-20

Locations

1 site across 1 country: Germany