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MyoSure Hysteroscopic Tissue Removal System Registry Study

Phase 4
18 Years
65 Years
Open (Enrolling)
Uterine Fibroids, Polyps

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Trial Information

MyoSure Hysteroscopic Tissue Removal System Registry Study

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.

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 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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Procedure Efficacy

Outcome Description:

Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatmet procedure

Outcome Time Frame:

1 hour post treatment

Safety Issue:


Principal Investigator

Edward Evantash

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hologic, Inc.


United States: Institutional Review Board

Study ID:

TMP 200905



Start Date:

November 2010

Completion Date:

November 2013

Related Keywords:

  • Uterine Fibroids
  • Polyps
  • morcellator
  • hysteroscope
  • myomectomy
  • polypectomy
  • uterine fibroids
  • uterine polyps
  • Leiomyoma
  • Myofibroma
  • Polyps



Hologic, Inc. Marlborough, Massachusetts  01752