Neoplasms

All Conditions

Symptoms and General Pathology

Skin and Connective Tissue Diseases

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Leiomyoma

Hemorrhage

Myofibroma

Menorrhagia

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Connective Tissue

Connective Tissue Diseases

Uterine Hemorrhage

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Menstruation Disturbances

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

Investigational transvaginal clamp inserted one time for 6 hours.

Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Piet Hinoul, M.D.

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.

The GYNECARE GYNOCCLUDE D-UAO Instruments are single-use disposable instruments consisting of a GYNECARE GYNOCCLUDE Uterine Stabilizer, a GYNECARE GYNOCCLUDEM Introducer Sheath, a GYNECARE GYNOCCLUDE Doppler Clamp, and a GYNECARE GYNOCCLUDE Coupler.

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

A Pivotal Study of Doppler Guided Uterine Artery Occlusion as Treatment for the Reduction of Fibroid Associated Bleeding

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.

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.

Participants categorized as "better" in the total UFS-QOL questionnaire, indicating an overall improvement in health-related quality of life. On this scale, higher scores are indicative of better quality of life, with a maximum(best)score of 100 and a minimum (worst)score of 0. "Better" was defined as a change of +12 or more from baseline at 12 mo.

Number of participants with continuation of menstrual cycles without interruption for three consecutive months

Number of participants with responses of either "satisfied" or "very satisfied" on a qualitative survey that ranged from "very dissatisfied" (worst) to "very satisfied" (best)

Number of participants with a minimum 15% decrease in fibroid bulk based on independent magnetic resonance imaging (MRI) review from baseline at 12 mo.

Note: As per protocol, MRIs were planned only for subjects 1 - 40, 81 - 120, and 161-200.

Number of participants categorized as "better" in the UFS-QOL sympton severity questionnaire, indicating an overall improvement in fibroid related symptoms. On this scale, higher scores are indicative of increasing symptom distress, with a maximum(worst)score of 100 and a minimum (best)score of 0. "Better" was defined as a change of -11 or less from baseline at 12 mo.

Ethicon, Inc.

Due to early study termination the longest timeframe of a patient's study participation was 2 years and 9 days. The shortest timeframe of study participation was 11 months 9 days.

DUAO Device

Age Continuous

Sex: Female, Male

United States

Mexico

Canada

Region of Enrollment

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.

Piet Hinoul MD

Doppler-guided uterine artery occlusion device

No Surgical Re-intervention

Improvement in Pictorial Blood Loss Assessment Chart (PBLAC) Score

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

Maintenance of Menses

Undecided

Very Dissatisfied

Dissatisfied

Satisfied

Very Satisfied

Procedural Satisfaction

ITT (Due to early termination, only 39 subjects had MRIs. No data for 8 participants.)

Spots Global Cancer Trial Database for Doppler-Guided Uterine Artery Occlusion (DUAO) Device for Fibroid Related Bleeding

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial