Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization

NCT02884960 | Unknown

• 1 other identifier: 1166710
• Study Type: interventional
• Target: 118
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of Embozene Microspheres compared with Embosphere Microspheres for the treatment of symptomatic uterine fibroids. A total of 118 patents with symptomatic uterine fibroids will be enrolled at 6 sites. Symptom severity, health-related quality of life, and the appearance of the fibroids will be assessed prior to treatment. Patients will then undergo the uterine fibroid embolization procedure with either Embosphere Microspheres or Embozene Microspheres, which will be randomly assigned. Clinical outcomes will be assessed 1 month, 3 months, 6 months and 12 months after the procedure, and imaging outcomes will be obtained 3 months after the procedure.

Conditions

Uterine Fibroids

Keywords

Uterine Fibroids; Embolization

Outcome Measures

Primary Outcomes (1)

• Fibroid Infarction Rate

  The primary effectiveness endpoint for this study is the proportion of patients with a global rate of infarction for all fibroids present within the uterus that is \>90% as seen on contrast-enhanced MRI.

  3 Months

Secondary Outcomes (5)

• Symptom Severity

  12 Months

• Health-Related Quality of Life

  12 Months

• Uterine Volume

  3 Months

• Dominant Fibroid Volume

  12 Months

• Frequency of Adverse Events After Treatment

  12 Months

Study Arms (2)

Embozene Microspheres

EXPERIMENTAL

Patients will undergo the uterine fibroid embolization procedure with Embozene Microspheres as the embolic agent.

Procedure: Uterine Fibroid Embolization

Embosphere Microspheres

ACTIVE COMPARATOR

Patients will undergo the uterine fibroid embolization procedure with Embosphere Microspheres as the embolic agent.

Procedure: Uterine Fibroid Embolization

Interventions

Uterine Fibroid Embolization PROCEDURE

This procedure involves the administration of the study device into the uterine arteries to block the flow of blood in these vessels. This deprives fibroid tumors within the uterus of their blood flow, which can cause the tumors to die. This in turn can lead to the relief of symptoms associated with fibroids.

Embosphere Microspheres; Embozene Microspheres

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• She is able to provide informed consent and sign the Institutional Review Board approved informed consent form.
• She is pre-menopausal and 30-50 years of age at the time of enrollment.
• She is not actively attempting to become pregnant for a minimum of 1 year after UFE, or practicing abstinence and willing to continue for a minimum of 1 year after UFE, or is surgically sterile.
• She is suffering from clinically significant symptoms attributed to the presence of uterine fibroids including abnormal menstrual bleeding and/or bulk-related symptoms including pelvic pain/discomfort, abdominal distension, urinary symptoms (including but not limited to increased urinary frequency or urinary hesitancy), and/or dyspareunia.

You may not qualify if:

• She has a history of pelvic malignancy.
• She is pregnant or intends to become pregnant within 12 months of the planned UFE procedure.
• She has had an abnormal PAP smear (anything other than normal or ASCUS - Atypical Squamous Cells of Unknown Significance) within 12 months of the planned UFE procedure.
• She has a coexisting condition that might explain the presenting symptoms (including but not limited to adenomyosis, endometrial hyperplasia, endometriosis, and complex ovarian cysts).
• She has evidence of current or recent pelvic inflammatory disease or uterine infection.
• She has another serious medical condition that might preclude full participation in the study to the desired endpoint (e.g., uncontrolled diabetes, malignancy, chronic obstructive pulmonary disease, myocardial infarction, congestive heart failure, etc.)
• She has a severe contrast allergy or renal insufficiency that would represent a contraindication to the administration of iodine-based or gadolinium-based contrast agents.
• She has a contraindication to magnetic resonance imaging (MRI).
• She has one or more MRI findings including a uterine size \>20 cm in greatest length, a dominant fibroid with a greatest diameter \>12 cm, an intracavitary submucosal fibroid, or non enhancing dominant fibroids.
• In the judgment of the investigator, she is unable or unlikely to be able to comply with the study procedures and requirements.

Sponsors & Collaborators

• Gary Siskin, MD: lead
• Boston Scientific Corporation: collaborator

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Gary Siskin, MD

  Community Care Physicians

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara MacDowell

CONTACT

518-262-5149; macdowb@mail.amc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Chairman, Department of Radiology, Albany Medical Center

Study Record Dates

• First Submitted: August 26, 2016
• First Posted: August 31, 2016
• Study Start: October 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: September 1, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share