CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 290 enrolled
Drug / intervention
MyoSure Tissue Removal Systemdevice
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/NCT01369758
NCT01369758N/ACompleted
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MyoSure Hysteroscopic Tissue Removal System Registry Study

Hologic, Inc.·interventional·Posted Jun 9, 2011·Updated Sep 13, 2017

In Brief

A clinical study evaluating MyoSure Tissue Removal System for Uterine Fibroids and Polyps. Completed, enrolled 290 participants across 1 site.

Detailed Summary

The objective of this study is to demonstrate the safety and effectiveness of community gynecologist initiated treatment of intra-uterine polyps and submucosal fibroids with the MyoSure Hysteroscopic Tissue Removal System in a significantly sized patient population.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUterine Fibroids, Polyps
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJun 9, 2011
Enrollment StartNov 1, 2010
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 15.1 years ago

Interventions

MyoSure Tissue Removal Systemdevice

The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.