CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 51 enrolled
Drug / intervention
Global Fibroid Ablation +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01750008
NCT01750008N/ACompleted

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

Acessa Health, Inc.·interventional·Posted Dec 17, 2012·Updated Nov 20, 2018

In Brief

A clinical study evaluating Global Fibroid Ablation and Myomectomy for Uterine Fibroids and Myomas. Completed, enrolled 51 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 17, 2012
Enrollment StartNov 1, 2012
Primary CompletionSep 1, 2013
Study CompletionJun 1, 2018
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.5 years ago

Interventions

Global Fibroid Ablationprocedure

Myomectomyprocedure