HOME Study: Hysteroscopic Office Myomectomy Evaluation

NCT01152112 | Completed Results

• 1 other identifier: TMP 2009003
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Uterine Fibroids; Polyps

Keywords

morcellator; hysteroscope; myomectomy; polypectomy; uterine fibroids; uterine polyps; office; cost; local anesthetic; cervical block; pain management

Outcome Measures

Primary Outcomes (1)

• Percent Reduction in Target Pathology Volume

  Percent reduction in target pathology volume, compared between pre-treatment baseline and 3 months post MyoSure treatment

  Three months post treatment

Secondary Outcomes (2)

• Percent of Subjects That Achieve 100% Removal of Target Pathology

  Three months post treatment

• Subject Self-reported Pain Score Occurring During the Treatment Procedure

  1 hour post treatment

Study Arms (2)

Treatment, Office Setting, myomectomy

EXPERIMENTAL

Myomectomy for uterine polyps and/or fibroids occurring in an office setting

Device: Myomectomy

Treatment, Hospital Setting, myomectomy

EXPERIMENTAL

Myomectomy for uterine polyps and/or fibroids occurring in a hospital setting

Device: Myomectomy

Interventions

Myomectomy DEVICE

Removal of fibroids and / or polyps

Also known as: Fibroid removal, Polyp removal

Treatment, Hospital Setting, myomectomy; Treatment, Office Setting, myomectomy

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hologic, Inc.: lead

Study Sites (9)

Phoenix Gynecology Consultants

Phoenix, Arizona, 85013, United States

Location

Boulder Women's Clinic

Boulder, Colorado, 80303, United States

Location

Women's Health Care Practice

Champaign, Illinois, 61820, United States

Location

The Research Division for Integrated Health Services

Ann Arbor, Michigan, 48106, United States

Location

Rubino OB/Gyn

West Orange, New Jersey, 07052, United States

Location

Williams, Benavides, Marston, & Kaminski

Raleigh, North Carolina, 27609, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43231, United States

Location

Kulbresh Women's Center

Irmo, South Carolina, 29063, United States

Location

Obstetrics and Gynecology

North Charleston, South Carolina, 29406, United States

Location

MeSH Terms

Conditions

Leiomyoma; Polyps; Agnosia

Interventions

Uterine Myomectomy

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Christina Mastandrea / Clinical Research manager
• Organization: Hologic, Inc.

christina.mastandrea@hologic.com

5082638772

Study Officials

• Edward Evantash, MD

  Sponsor GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2010
• First Posted: June 29, 2010
• Study Start: June 1, 2010
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2013
• Last Updated: September 13, 2017
• Results First Posted: September 13, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (9)