Trials / Withdrawn
WithdrawnNCT00768742
Safety and Effectiveness Study of RF Ablation of Uterine Fibroids to Reduce Menstrual Bleeding: the Fibroid Ablation Study
Clinical Study to Assess the Safety and Effectiveness of VizAblate(tm) Intrauterine Ultrasound-guided RF Ablation (IUUSgRFA) of Submucosal and Intramural Uterine Fibroids on the Reduction of Pictorial Blood Loss Assessment Scores
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Gynesonics · Industry
- Sex
- Female
- Age
- 25 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2008-09-01
- Primary completion
- 2010-11-01
- Completion
- 2010-11-01
- First posted
- 2008-10-08
- Last updated
- 2013-11-25
Locations
3 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT00768742. Inclusion in this directory is not an endorsement.