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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT00768742
Other study ID # CL00635
Secondary ID HC-126128
Status Withdrawn
Phase N/A
First received October 6, 2008
Last updated November 22, 2013
Start date September 2008
Est. completion date November 2010

Study information

Verified date November 2013
Source Gynesonics
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to test the hypothesis that a minimum 75% volume radiofrequency ablation of fibroids associated with menorrhagia results in reduction of menstrual bleeding.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers No
Gender Female
Age group 25 Years and older
Eligibility Inclusion Criteria:

- Pre-menopausal

- Regular, consistent menstrual cycles

- Serum progesterone > 6 ng/ml (19 nmol/L)

- 2 months history of PBLAC score of 150-500

- Maximum of 4 type I, type II, or intramural fibroids

- Patient is at low risk for cervical cancer

- Hemoglobin > 6 g/dl

- Not at risk for pregnancy

- No desire for future fertility

- Willing and able to complete the follow-up requirements outlined in the study design section of the protocol

- Willing to sign a consent form

Exclusion Criteria:

- Subserosal fibroids.

- Any fibroid that obstructs access to the endometrial cavity

- FSH > 20 IU/L

- Pregnancy

- Evidence of disorders of hemostasis

- Use of GnRH agonist or depomedroxyprogesterone acetate or other implantable or injectable progestin and/or estrogen

- SERMS/SPRMS within the last 6 months

- Current use of any IUD or use of Mirena IUS within the last 3 months

- Gynecological malignancy or hyperplasia

- Known/suspected abdominal/pelvic cancer

- Active pelvic infection (e.g., active salpingitis or other pelvic inflammatory disease)

- Adenomyosis

- Previous surgical or ablative treatment for fibroids or menorrhagia

- Previous uterine artery embolization or occlusion

- Patient on anti-coagulation therapy

- Needing emergency surgery to treat fibroid symptoms

- Concomitant intrauterine polyps.

- Major medical or psychiatric illness affecting general health or patient's ability to comply with follow-up schedule or provide valid patient self-assessment data

- Contraindication to MRI

- Allergy to contrast media

- Mild renal insufficiency or worse

- Known renal disease

- Uncontrolled hypertension lasting 2 years or more

- Diabetes

- Uterine size > 10 weeks or 10 cm from ectocervix to fundus.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
VizAblate Intrauterine Ultrasound-Guided RF Ablation
VizAblate enables a minimally invasive procedure to visualize, target and treat uterine fibroids using ultrasound visualization and RF energy.

Locations

Country Name City State
Canada Shirley E. Greenberg Women's Health Centre, The Ottawa Hospital Ottawa Ontario
Canada St. Joseph's Health Centre Toronto Ontario
Canada Victoria General Hospital; Mature Women's Centre Winnipeg Manitoba

Sponsors (1)

Lead Sponsor Collaborator
Gynesonics

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Menstrual bleeding as measured by the Pictorial Blood Loss Assessment Chart (PBLAC) Baseline, 3 mo, 6 mo, 9 mo, 12 mo No
Secondary Rate of surgical reintervention 12 mo No
Secondary Quality of Life questionnaires Baseline, 3 mo, 6 mo, 9 mo, 12 mo No
Secondary Time required to return to normal daily activity 7-14 days No
Secondary Adverse events At time of discharge, 7-14 days, 3 mo, 6 mo, 9 mo, 12 mo. Yes
Secondary Subject tolerance of procedure rated via analog visual scale Discharge No
Secondary Fibroid dimension and non-perfused volume Baseline, 1 day, 3 mo, 6 mo, 9 mo, and 12 mo No
Secondary Pregnancy and pregnancy-related complications 3 mo, 6 mo, 9 mo, and 12 mo Yes
See also
  Status Clinical Trial Phase
Completed NCT01441635 - Safety and Efficacy of Elagolix in Pre-Menopausal Women With Heavy Uterine Bleeding and Uterine Fibroids Phase 2
Completed NCT00958334 - Extension Study of Proellex in Women Who Have Previously Completed Study ZPU 003 Phase 2
Withdrawn NCT04567589 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada
Recruiting NCT05078307 - Evaluation of a Hysteroscopic Method With Vaporization in the Hysteroscopic Treatment of Submucosal Uterine Fibroids N/A
Recruiting NCT02283502 - Clinical Test of the MRgHIFU System on Uterine Fibroids Phase 1
Completed NCT01631903 - Extension of Study ZPV-200 Phase 2
Completed NCT01739621 - Safety, Pharmacokinetics and Efficacy of Proellex® (Telapristone Acetate) Administered Vaginally in the Treatment of Premenopausal Women With Uterine Fibroids Who Have Completed ZPV-200 Phase 2
Completed NCT00152256 - A Study to Evaluate of the Safety and Effectiveness of Asoprisnil in Treating Women With Uterine Fibroids Phase 3
Not yet recruiting NCT03586947 - Association Between Vitamin D and the Risk of Uterine Fibroids N/A
Completed NCT02925494 - An Extension Study to Evaluate the Efficacy and Safety of Elagolix in Premenopausal Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids Phase 3
Not yet recruiting NCT06055114 - Study on Vaginal Microecology and Cervical Local Immune Function in Patients With Uterine Fibroids of Childbearing Age
Terminated NCT05026502 - A Study to Assess Patient-Reported Quality of Life and Effectiveness on Control of Bleeding in Adult Participants With Heavy Menstrual Bleeding Due to Uterine Fibroids Taking Oral Oriahnn Capsules
Withdrawn NCT04567095 - A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Patients in Canada
Withdrawn NCT03699176 - Assessment of Safety and Efficacy of Vilaprisan in Subjects With Uterine Fibroids Phase 3
Not yet recruiting NCT02884960 - Safety and Efficacy of Embozene Microspheres for Uterine Fibroid Embolization N/A
Completed NCT02472184 - Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy N/A
Terminated NCT01555073 - Preemptive Analgesia Following Uterine Artery Embolization Phase 4
Completed NCT01452659 - Efficacy and Safety of TAK-385 in the Treatment of Uterine Fibroids Phase 2
Completed NCT01229826 - Magnetic Resonance Elastography (MRE) of Uterine Fibroids N/A
Terminated NCT00785356 - Safety and Efficacy of Proellex in Pre-Menopausal Anemic Women With Symptomatic Uterine Fibroids Phase 3