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

NCT00496080 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2012-09-10

Study results available
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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

Interventions

DEVICE

Doppler-Guided Uterine Artery Occlusion Device (DUAO)

Investigational transvaginal clamp inserted one time for 6 hours.

Sponsors & Collaborators

  • Ethicon, Inc.

    lead INDUSTRY

Principal Investigators

  • Piet Hinoul, M.D. · Ethicon, Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
25 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • United States
  • Canada
  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00496080 on ClinicalTrials.gov