MyoSure Hysteroscopic Tissue Removal System Registry Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01369758
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Information provided by (Responsible Party):
Hologic, Inc.

Brief 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.

Condition or disease Intervention/treatment Phase
Uterine Fibroids Polyps Device: MyoSure Tissue Removal System Not Applicable

Detailed Description:
Between 500 and 600 subjects will be enrolled in a prospective, multi-center registry study. Approximately 100 of these cases will be completed in an office setting, with the remaining 400-500 cases completed in a hospital outpatient or ambulatory surgery center. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps and submucosal fibroids.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 290 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: MyoSure Hysteroscopic Tissue Removal System Registry Study
Study Start Date : November 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Uterine Fibroids
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Intrauterine pathology, myomectomy
Subjects with intrauterine fibroids and/or polyps will undergo intrauterine pathology removal using the MyoSure Tissue Removal System; myomectomy procedure.
Device: MyoSure Tissue Removal System
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.
Other Name: Myomectomy procedure

Primary Outcome Measures :
  1. Procedure Efficacy [ Time Frame: 1 hour post treatment ]
    Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatment procedure

Secondary Outcome Measures :
  1. Percentage of Subjects That Achieve 100% Removal of Target Pathology [ Time Frame: 1 hour post treatment ]
    Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Healthy female between 18 and 65 years of age
  2. Subject must be able to understand, read and sign the study specific informed consent forms after the nature of the study has been fully explained to her
  3. Subject is indicated for myomectomy or polypectomy
  4. Subject exhibits intrauterine polyps and/or submucous myomas which meet one of the following criteria. In cases of subjects with multiple intrauterine pathology, classification is based as follows:

    • All polyps
    • All Type 0, Type 1 or Type 2 myomas ≤ 6 cm in diameter
    • Polyps plus Type 0, Type 1 or Type 2 myomas ≤6 cm in diameter

Exclusion Criteria:

  1. Subject is pregnant
  2. Subject has an Intrauterine Device (IUD) at the time of the procedure. A subject may be enrolled in the study if the IUD is removed prior to the treatment procedure
  3. Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
  4. Active pelvic inflammatory disease or pelvic/vaginal infection
  5. Subject has a known or suspected coagulopathy or bleeding disorder
  6. Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
  7. Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01369758

United States, Massachusetts
Hologic, Inc.
Marlborough, Massachusetts, United States, 01752
Sponsors and Collaborators
Hologic, Inc.
Principal Investigator: Edward Evantash Hologic, Inc.

Responsible Party: Hologic, Inc. Identifier: NCT01369758     History of Changes
Other Study ID Numbers: TMP 200905
First Posted: June 9, 2011    Key Record Dates
Results First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hologic, Inc.:
uterine fibroids
uterine polyps

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Connective Tissue Diseases