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Uterine Artery Occlusion for Fibroid Related Bleeding

Primary Purpose

Menorrhagia, Uterine Fibroids

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Doppler-Guided Uterine Artery Occlusion Device
Sponsored by
Ethicon, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Menorrhagia focused on measuring Fibroids, Menorrhagia, Menorrhagia associated with uterine fibroids

Eligibility Criteria

25 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 25 to 50 years of age
  • Subject has a negative urine or blood pregnancy test prior to the procedure. At the time of enrollment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12 months of the study period (unless sterilized)
  • Normal pap smear within 36 months of study procedure (most recent)
  • Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement)
  • At least one intra-mural or sub-serosal or sub-mucosal uterine fibroid with a minimum diameter of greater than or equal to 3 cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound
  • Symptomatic subject presenting with at least one of the following fibroid symptoms: pelvic pressure, menorrhagia, metrorrhagia, pelvic pain, increasing abdominal girth or dyspareunia due to fibroids.
  • Subject has evidence of bilateral ureteric flow
  • Subject agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Ethics Committee-approved informed consent.

Exclusion Criteria:

  • Pregnancy as confirmed by positive urine or blood pregnancy test
  • Menopausal as defined by elevated follicle-stimulating hormone (FSH) and decreased oestradiol hormone levels as determined by the hospital local laboratory reference range criteria
  • Presence of any pedunculated sub-mucosal or pedunculated sub-serosal fibroid(s) as determined by MRI, ultrasound or hysteroscopy
  • Presence of an intra-uterine device (IUD)
  • Any hydronephrosis as determined on renal ultrasound prior to the procedure
  • Clinical history of any thrombo-embolic disease or known thrombophilia
  • Blood Urine Nitrogen (BUN) greater than 7.2mmol/L* and/or serum creatinine greater than 106μmol/L* unresolved with change in diet or hydration
  • History or current evidence of gynecologic malignancy (confirmed by hysteroscopy or endometrial biopsy), atypical endometrial hyperplasia, or chronic pelvic inflammatory disease
  • Pelvic mass outside the uterus other than uterine fibroids
  • Any current acute or chronic systemic infection or localized pelvic infection, including a urinary tract infection
  • Use of Gonadotropin-Releasing Hormone (GnRH) agonist, danozol or mifepristone within 6-months prior to the start of the study procedure
  • Using anticoagulation therapy (except over the counter treatments (e.g. aspirin)), or have an underlying bleeding disorder
  • Unsuitable for MRI examination (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices)
  • Prior endometrial ablation, uterine artery embolization, or uterine artery ligation
  • Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease);

Sites / Locations

  • Viborg County Hospital
  • University Hospital
  • Service de Gynecologie Obsterique, Hopital Antoine Beclere
  • Maternite les Bazennes
  • CHRU de Lille, Hopital Jeanne de Flandre
  • Universitaeklinikum Erlangen
  • Universitats-Frauenklinik Tubingen
  • VU Medical Center
  • Ullevaal University
  • Universitats-Frauenklinik
  • M1 Maternity, Bradford Royal Infirmary
  • Hull and East Yorkshire Women & Children Hospital
  • Elizabeth Garret Anderson Hospital
  • Queen Elizabeth the Queen Mother Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

DUAO Device

Outcomes

Primary Outcome Measures

Lack of surgical re-intervention

Secondary Outcome Measures

Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.
Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.
Mean HRQL subscales.
Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.
Mean change in PBLAC scores.
Percentage of subjects with decrease in fibroid load based on independent MRI review.
Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months
Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.
Lack of surgical re-intervention.
Pain score
Days to normal activities (household, work and sexual intercourse)
Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)
Nights in hospital

Full Information

First Posted
July 3, 2007
Last Updated
March 8, 2011
Sponsor
Ethicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00496067
Brief Title
Uterine Artery Occlusion for Fibroid Related Bleeding
Official Title
An Evaluation of a Doppler-Guided Uterine Artery Occlusion Device as Treatment for the Reduction of Fibroid-Associated Bleeding
Study Type
Interventional

2. Study Status

Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Data required further pilot work to be undertaken.
Study Start Date
April 2007 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ethicon, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of this study is to evaluate the safety and effectiveness of Doppler guided Uterine Artery Occlusion (D-UAO) as treatment for the reduction of fibroid-associated symptoms.
Detailed Description
DUAO is intended for bilateral occlusion of the uterine arteries

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Menorrhagia, Uterine Fibroids
Keywords
Fibroids, Menorrhagia, Menorrhagia associated with uterine fibroids

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
DUAO Device
Intervention Type
Device
Intervention Name(s)
Doppler-Guided Uterine Artery Occlusion Device
Other Intervention Name(s)
floSTAT
Intervention Description
For bilateral occlusion of the uterine arteries
Primary Outcome Measure Information:
Title
Lack of surgical re-intervention
Time Frame
Post-op through end of study
Secondary Outcome Measure Information:
Title
Percentage of subjects with improvement in Uterine Fibroid Symptom Quality of Life (UFS-QOL) Symptom Severity and Health Related Quality of Life (HRQL) scores.
Time Frame
6, 12 and 24 months
Title
Mean improvement in UFS-QOL Symptom Severity and HRQL transformed scores.
Time Frame
6, 12 and 24 months
Title
Mean HRQL subscales.
Time Frame
6, 12 and 24 months
Title
Percentage of subjects with reduction of 50% or greater in Pictorial Blood Loss Assessment Chart (PBLAC) score.
Time Frame
6 and 12 months
Title
Mean change in PBLAC scores.
Time Frame
Baseline to 6 and 12 months
Title
Percentage of subjects with decrease in fibroid load based on independent MRI review.
Time Frame
6 months
Title
Percentage of subjects with maintenance of menses as defined by continuation of menstrual cycles without an interruption of three consecutive months
Time Frame
12 months
Title
Percentage of subjects with procedural satisfaction as defined by responses of either satisfied or very satisfied.
Time Frame
12 months
Title
Lack of surgical re-intervention.
Time Frame
24 months
Title
Pain score
Time Frame
Discharge or 24-hour post clamp removal, whichever is earlier
Title
Days to normal activities (household, work and sexual intercourse)
Time Frame
Post procedure
Title
Euro-QOL expressed as change from baseline for each of the 6 domains and Visual Analogue Scale (VAS)
Time Frame
1, 3, 6 and 12 months
Title
Nights in hospital
Time Frame
Total and post procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 25 to 50 years of age Subject has a negative urine or blood pregnancy test prior to the procedure. At the time of enrollment to the study, the subject has no intent of further childbearing and intends to use appropriate contraception throughout the first 12 months of the study period (unless sterilized) Normal pap smear within 36 months of study procedure (most recent) Cervix suitable for tenaculum placement as determined by pelvic exam (adequate length of cervix, absence of cervical fibroid/lower fibroid to prevent clamp placement) At least one intra-mural or sub-serosal or sub-mucosal uterine fibroid with a minimum diameter of greater than or equal to 3 cm, and all fibroids with a diameter less than or equal to 8cm with a prevailing pathology (e.g., as opposed to adenomyosis) of fibroids determined through ultrasound Symptomatic subject presenting with at least one of the following fibroid symptoms: pelvic pressure, menorrhagia, metrorrhagia, pelvic pain, increasing abdominal girth or dyspareunia due to fibroids. Subject has evidence of bilateral ureteric flow Subject agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the Ethics Committee-approved informed consent. Exclusion Criteria: Pregnancy as confirmed by positive urine or blood pregnancy test Menopausal as defined by elevated follicle-stimulating hormone (FSH) and decreased oestradiol hormone levels as determined by the hospital local laboratory reference range criteria Presence of any pedunculated sub-mucosal or pedunculated sub-serosal fibroid(s) as determined by MRI, ultrasound or hysteroscopy Presence of an intra-uterine device (IUD) Any hydronephrosis as determined on renal ultrasound prior to the procedure Clinical history of any thrombo-embolic disease or known thrombophilia Blood Urine Nitrogen (BUN) greater than 7.2mmol/L* and/or serum creatinine greater than 106μmol/L* unresolved with change in diet or hydration History or current evidence of gynecologic malignancy (confirmed by hysteroscopy or endometrial biopsy), atypical endometrial hyperplasia, or chronic pelvic inflammatory disease Pelvic mass outside the uterus other than uterine fibroids Any current acute or chronic systemic infection or localized pelvic infection, including a urinary tract infection Use of Gonadotropin-Releasing Hormone (GnRH) agonist, danozol or mifepristone within 6-months prior to the start of the study procedure Using anticoagulation therapy (except over the counter treatments (e.g. aspirin)), or have an underlying bleeding disorder Unsuitable for MRI examination (e.g. severe claustrophobia, non-MRI-compatible implanted metalloid devices) Prior endometrial ablation, uterine artery embolization, or uterine artery ligation Poor procedural candidate due to medical conditions as determined by the investigator (e.g. anesthesia class, renal insufficiency, heart disease);
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Robinson, MD
Organizational Affiliation
Ethicon, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Viborg County Hospital
City
Viborg
ZIP/Postal Code
DK-8800
Country
Denmark
Facility Name
University Hospital
City
Angers cedex
ZIP/Postal Code
49033
Country
France
Facility Name
Service de Gynecologie Obsterique, Hopital Antoine Beclere
City
Clamart Cedex
ZIP/Postal Code
92414
Country
France
Facility Name
Maternite les Bazennes
City
Dunkerque
ZIP/Postal Code
59430
Country
France
Facility Name
CHRU de Lille, Hopital Jeanne de Flandre
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Universitaeklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitats-Frauenklinik Tubingen
City
Tubingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
VU Medical Center
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Ullevaal University
City
Oslo
ZIP/Postal Code
N-0407
Country
Norway
Facility Name
Universitats-Frauenklinik
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
M1 Maternity, Bradford Royal Infirmary
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Hull and East Yorkshire Women & Children Hospital
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom
Facility Name
Elizabeth Garret Anderson Hospital
City
London
ZIP/Postal Code
WC1E 6DH
Country
United Kingdom
Facility Name
Queen Elizabeth the Queen Mother Hospital
City
Margate
ZIP/Postal Code
CT9 4AN
Country
United Kingdom

12. IPD Sharing Statement

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Uterine Artery Occlusion for Fibroid Related Bleeding

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