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MyoSure Hysteroscopic Tissue Removal System Registry Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT01369758
First received: November 11, 2010
Last updated: November 20, 2012
Last verified: September 2012
History of Changes
  Purpose

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 Intervention Phase
Uterine Fibroids
Polyps
 Device: MyoSure Tissue Removal System
 Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: MyoSure Hysteroscopic Tissue Removal System Registry Study

Resource links provided by NLM:

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

Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • Procedure Efficacy [ Time Frame: 1 hour post treatment ] [ Designated as safety issue: No ]
    Mean percent of pathology removed, based on hysteroscopic assessment immediately following completion of the treatmet procedure


Secondary Outcome Measures:
  • Percentage of subjects that achieve 100% removal of target pathology [ Time Frame: 1 hour post treatment ] [ Designated as safety issue: No ]
    Percentage of subjects that achieve 100% removal of target pathology, as determined by hysteroscopic exam following the treatment procedures.


Estimated Enrollment: 600
Study Start Date: November 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369758

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

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01369758     History of Changes
Other Study ID Numbers: TMP 200905
Study First Received: November 11, 2010
Last Updated: November 20, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hologic, Inc.:
morcellator
hysteroscope
myomectomy
 polypectomy
uterine fibroids
uterine polyps

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Polyps
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on June 18, 2013