Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

NCT00496080 | Terminated Results DMC

• 1 other identifier: 300-06-004
• Study Type: interventional
• Target: 87
• Locations: 3 countries
• Sites: 11

Brief Summary

The objective of this study is to evaluate the safety and effectiveness of Doppler guided uterine artery occlusion (D-UAO) for the reduction of fibroid associated bleeding.

Conditions

Menorrhagia; Uterine Fibroids

Keywords

Menorrhagia associated with Uterine Fibroids

Outcome Measures

Primary Outcomes (2)

• No Surgical Re-intervention

  Number of participants without any subsequent surgical procedure intended to manage fibroid symptoms performed. Potential procedures included surgical hysterectomy or dilatation and curettage (D\&C) for treatment of menorrhagia; uterine artery embolization (UAE) or laparoscopic uterine artery occlusion; endometrial resection or ablation; myomectomy or myolysis.

  Study completion

• Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score

  Number of participants with a 50% or greater reduction in PBLAC score from baseline at 12 mo and a PBLAC score of less than 250. PBLAC is a simple validated semiquantitative method of measuring total menstrual blood loss using a pictorial representation of blood loss, where higher scores indicate more blood loss. This hybrid endpoint combined the reduction in PBLAC score with the total PBLAC score.

  From baseline to 12 months

Secondary Outcomes (5)

• Mean Improvement in Health Related Quality of Life (HRQOL) Scores

  From baseline to 12 months

• Maintenance of Menses

  12 months

• Procedural Satisfaction

  12 months

• Decrease in Fibroid Bulk

  From baseline to 12-months

• Mean Improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity Scores

  From baseline to 12 months

Study Arms (1)

DUAO Device

EXPERIMENTAL

Doppler-guided uterine artery occlusion device (Single-arm study)

Device: Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Interventions

Doppler-Guided Uterine Artery Occlusion Device (DUAO) DEVICE

Investigational transvaginal clamp inserted one time for 6 hours.

Also known as: floSTAT

DUAO Device

Eligibility Criteria

• Age: 25 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• to 50 years of age;
• PBLAC score of 150 or greater;
• Completed child-bearing;
• Normal Pap smear within 12 months;
• Cervix suitable for tenaculum placement as determined by pelvic exam;
• At least one uterine fibroid of 3 cm diameter or greater with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound;
• Willing to maintain use or non-use of hormonal contraception from 3 months pre-study throughout the 12-month follow-up period;
• Willing to maintain use or non-use of anti-fibrinolytic agents from 3 months pre-study throughout the 12-month follow-up period;
• Able to tolerate the required prolonged supine position during treatment (approximately 6 hours);
• Willing and able to provide informed consent and to follow study-related requirements;

You may not qualify if:

• Pregnancy (as confirmed immediately prior to procedure)
• Fibroid diameter greater than 8.0 cm determined through transvaginal ultrasound; \[or if 2 dimensions are measured, total dimension greater than 16 cm; or if the 3 dimensions (length, height, width) are measured, total dimension greater than 24 cm\];
• Presence of a pedunculated fibroid determined by ultrasound; hysteroscopy, or saline infused sonography;
• Hydronephrosis as determined by radiologist interpretation on renal ultrasound pre-procedurally;
• Menopausal;
• Clinical history of any thromboembolic disease;
• Blood urine nitrogen (BUN) greater than 20 mg/dL and/or serum creatinine greater than 1.2 mg/dL unresolved with change in diet or hydration; · One or more lower uterine segment fibroids determined through pelvic exam;
• History of gynecologic malignancy, atypical endometrial hyperplasia, or pelvic inflammatory disease;
• Abnormal endometrial biopsy within the last 6 months prior to procedure;
• Pelvic mass outside the uterus suggesting other disease processes;
• Any current acute or chronic systemic infection or localized pelvic infection, including an unresolved urinary tract infection;
• Using GnRH agonist or mifepristone within 6-months prior to the start of the study;
• An intrauterine device (IUD) in place;
• Using anticoagulation therapy (except OTC treatments (e.g. aspirin)), or have an underlying bleeding disorder;
• Unsuitable for MRI examination, if within study subgroup to undergo MRI evaluation (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices);

Sponsors & Collaborators

• Ethicon, Inc.: lead

Study Sites (11)

Women's Health Research

Phoenix, Arizona, 85015-2110, United States

Location

Holy Cross Medical Group

Fort Lauderdale, Florida, 33308, United States

Location

University Women's Care - Wayne State University

Southfield, Michigan, 48034, United States

Location

Minnesota Gynecology and Surgery

Edina, Minnesota, 55435, United States

Location

St. Luke's Hospital

Chesterfield, Missouri, 63017, United States

Location

North Carolina Children's & Adults' Clinical Research Foundation

Chapel Hill, North Carolina, 27514, United States

Location

Complete Healthcare for Women

Columbus, Ohio, 43231, United States

Location

Hahnemann University Hospital - Drexel University School of Med.

Philadelphia, Pennsylvania, 19102, United States

Location

Matlock Ob/Gyn

Arlington, Texas, 76014, United States

Location

St. Joseph's Health Care

London, Ontario, N6A 4V2, Canada

Location

Hospital Universitario

Monterrey, Nuevo León, 64460, Mexico

Location

MeSH Terms

Conditions

Menorrhagia; Leiomyoma

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Menstruation Disturbances; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

Study was terminated early because 6 mo interim analysis of parallel European study showed that device was not meeting the primary endpoint. Target enrollment was 200 subjects, but results are based on 87 subjects who were treated with the device.

Results Point of Contact

• Title: Piet Hinoul MD
• Organization: Ethicon

phinoul@its.jnj.com

908-218-2585

Study Officials

• Piet Hinoul, M.D.

  Ethicon, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: July 3, 2007
• First Posted: July 4, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: September 10, 2012
• Results First Posted: July 24, 2012

Record last verified: 2012-09

Locations

US (9); ME (1); CA (1)