Clinical trial NCT01152112: HOME Study: Hysteroscopic Office Myomectomy Evaluation
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Uterine Fibroids
Polyps
Keywords: morcellator
hysteroscope
myomectomy
polypectomy
uterine fibroids
uterine polyps
office
cost
local anesthetic
cervical block
pain management
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2010-06-29
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Percent Reduction in Target Pathology Volume
timeFrame: Three months post treatment
Secondary outcomes:
measure: Percent of Subjects That Achieve 100% Removal of Target Pathology
timeFrame: Three months post treatment
measure: Subject Self-reported Pain Score Occurring During the Treatment Procedure
timeFrame: 1 hour post treatment
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Gynecology Consultants
state: Arizona
city: Boulder
country: United States
facility: Boulder Women's Clinic
state: Colorado
city: Champaign
country: United States
facility: Women's Health Care Practice
state: Illinois
city: Ann Arbor
country: United States
facility: The Research Division for Integrated Health Services
state: Michigan
city: West Orange
country: United States
facility: Rubino OB/Gyn
state: New Jersey
city: Raleigh
country: United States
facility: Williams, Benavides, Marston, & Kaminski
state: North Carolina
city: Columbus
country: United States
facility: Complete Healthcare for Women
state: Ohio
city: Irmo
country: United States
facility: Kulbresh Women's Center
state: South Carolina
city: North Charleston
country: United States
facility: Obstetrics and Gynecology
state: South Carolina
Study officials:
affiliation: Sponsor GmbH
name: Edward Evantash, MD
role: STUDY_DIRECTOR
References: