HOME Study: Hysteroscopic Office Myomectomy Evaluation

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT01152112
First received: June 18, 2010
Last updated: September 10, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to demonstrate safety and effectiveness of the MyoSure Tissue Removal System when used by community gynecologists in an office setting for the treatment of patients with symptomatic intrauterine polyps and submucosal fibroids.


Condition Intervention
Uterine Fibroids
Polyps
Device: Myomectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Hysteroscopic Office Myomectomy Evaluation Using the MyoSure Tissue Removal System for the Removal of Uterine Fibroids and Polyps in the Treatment of Abnormal Uterine Bleeding (AUB)

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • Percent reduction in target pathology volume [ Time Frame: Three months post treatment ] [ Designated as safety issue: No ]
    Percent reduction in target pathology volume, compared between pre-treatment baseline and month 3 post MyoSure treatment assessments, as measured by saline infused sonohysterogram.


Secondary Outcome Measures:
  • Percent of subjects that achieve 100% removal of target pathology [ Time Frame: Three months post treatment ] [ Designated as safety issue: No ]
    Percent volume reduction of target pathology between baseline and month three post treatment assessments, as measured by saline infused sonohysterogram.

  • Subject self-reported pain score occurring during the treatment procedure [ Time Frame: 1 hour post treatment ] [ Designated as safety issue: No ]
    Mean difference in pain score compared between subject-rated assessment of pain occurring during a pap smear and pain occurring during the MyoSure treatment procedure, based on the Wong-Baker Faces Rating Scale (FRS)


Enrollment: 86
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment, Office Setting, myomectomy
Myomectomy for uterine polyps and/or fibroids occurring in an office setting
Device: Myomectomy
Removal of fibroids and / or polyps
Other Names:
  • Fibroid removal
  • Polyp removal
Experimental: Treatment, Hospital Setting, myomectomy
Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting
Device: Myomectomy
Removal of fibroids and / or polyps
Other Names:
  • Fibroid removal
  • Polyp removal

Detailed Description:

Approximately one hundred subjects will be enrolled in a randomized, comparative setting study conducted at 10-15 investigational sites. Sixty subjects will be randomized to undergo treatment in an office setting, and 40 subjects will be randomized to undergo treatment in a hospital or ambulatory surgical center (ASC) setting. Subjects will undergo a hysteroscopic tissue removal procedure to remove intrauterine polyps, type 0 fibroids, or type I fibroids. Saline infused sonohysterogram images (SIS) obtained at three months post treatment will be compared to pre-treatment images, to determine the percent reduction in target pathology volume. Additionally, subject self-reported pain scores (as rated on an 11 point scale) will compare pain occurring during the treatment procedure to the average pain level experienced during a PAP smear. Economic data will be collected and compared between the two treatment settings.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Healthy female between 18 and 55 years of age
  • 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
  • Subject is a pre-menopausal or peri-menopausal female, either nulliparous or parous
  • Subject is experiencing AUB as confirmed by a symptom raw score of 23 or a calculated symptom score of 44.0 or higher on the Uterine Fibroid Scale and Health Related Quality of Life (UFS-QOL)
  • Subject is indicated for myomectomy or polypectomy for benign appearing pathology, based on a hysteroscopic exam and measured by saline infused sonogram assessment within 30 days of the planned index procedure
  • Subject exhibits intrauterine polyps and/or submucous myomas which, in the opinion of the treating physician, are compatible with office-based treatment (e.g. 15 minutes or less of cutting time) using the MyoSure device and meet at least one of the following criteria:
  • One or more polyps, with at least one of the polyps ≥ 1.5 cm and ≤ 3.0 cm diameter and having broad based attachment to the uterine wall.
  • Up to two Type 0 or Type 1 myomas with at least one of the myomas being ≥ 1.5 cm and none of the myomas being 3.0 cm diameter

    • If the first myoma is 3.0 cm, the second myoma must be ≤ 2.0 cm
    • Fundal myomas must be Type 0
  • Polyps plus up to two Type 0 or Type I myomas with at least one of the myomas being ≥ 1.5cm and ≤ 3.0 cm
  • The subject demonstrates a negative pregnancy test within 48 hours prior to the planned index procedure
  • The subject must document a score of 5 or lower on the Pap Smear and Blood Draw scales of the Pain Tolerance Survey

Exclusion Criteria:

  • Subject has known or suspected cancer, including breast, endometrial, and ovarian
  • Contraindication and/or allergy to local anesthetic, or oral medications specified in the treatment protocol
  • The subject has a history of chronic narcotic use
  • Previous uterine artery embolization or other uterine artery occlusion procedure (Doppler or laparoscopic)
  • Subject has blood borne pathogens-HIV, hepatitis B, CJD, etc.
  • 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
  • Subject is taking an anticoagulant or antiplatelet medication other than low dose aspirin
  • Active pelvic inflammatory disease or pelvic/vaginal infection
  • Subject has a known or suspected coagulopathy or bleeding disorder
  • Subject has a history of unmanaged endocrine disease
  • Subject has current or past, acute or chronic psychiatric disorder which, in the opinion of the Investigator, may preclude proper evaluation and follow-up
  • Subject has a history of auto-immune, inflammatory, or connective tissue disease
  • Subject has a history of disease which increases the risk for fluid overload (i.e. significant cardiac, hepatic, or renal dysfunction)
  • Uncontrolled hypertension lasting two years or more
  • Use of any experimental drug or device within 30 days prior to the screening visit
  • The subject has a terminal illness that may prevent the completion of any follow-up assessments
  • Any employee or relative of an employee of the Sponsor company or any Investigator site employee or relative of employees working on the study
  • 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
  • Subject has one of the following:

    • Type II submucosal myoma
    • Type O or Type I submucosal myoma > 3.0 cm
    • Fundal Type I myoma
    • Highly vascularized myoma as determined by SIS or hysteroscopic examination
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01152112

Locations
United States, Arizona
Phoenix Gynecology Consultants
Phoenix, Arizona, United States, 85013
United States, Colorado
Boulder Women's Clinic
Boulder, Colorado, United States, 80303
United States, Illinois
Women's Health Care Practice
Champaign, Illinois, United States, 61820
United States, Michigan
The Research Division for Integrated Health Services
Ann Arbor, Michigan, United States, 48106
United States, New Jersey
Rubino OB/Gyn
West Orange, New Jersey, United States, 07052
United States, North Carolina
Obstetrics and Gynecology
North Charleston, North Carolina, United States, 29406
Williams, Benavides, Marston, & Kaminski
Raleigh, North Carolina, United States, 27609
United States, Ohio
Complete Healthcare for Women
Columbus, Ohio, United States, 43231
United States, South Carolina
Kulbresh Women's Center
Irmo, South Carolina, United States, 29063
Sponsors and Collaborators
Hologic, Inc.
Investigators
Study Director: Edward Evantash, MD Sponsor GmbH
  More Information

No publications provided

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01152112     History of Changes
Other Study ID Numbers: TMP 2009003
Study First Received: June 18, 2010
Last Updated: September 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Hologic, Inc.:
morcellator
hysteroscope
myomectomy
polypectomy
uterine fibroids
uterine polyps
office
cost
local anesthetic
cervical block
pain management

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 August 26, 2014