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The purpose of this study is to demonstrate the safety and effectiveness of radiofrequency ablation (RFA) using the Halt System for the treatment of patients with symptomatic uterine fibroids.
Full description
In this single-arm study, subjects who have symptomatic uterine fibroids will have laparoscopic surgery in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
Enrollment
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Inclusion criteria
Are premenopausal and ≥ 25 years old
Have symptomatic uterine fibroids
Have a uterine gestational size ≤14 weeks as determined by pelvic exam
Have ≤ 6 (six) treatable fibroids in whom no single fibroid exceeds 7 cm in any diameter as measured by ultrasound or magnetic resonance imaging (MRI). Only Fibroids greater than 1cm in diameter should be treated in this study
Have a total uterine fibroid volume that does not exceed 300cc on ultrasound or contrast-enhanced MRI evaluation
Have clinical menorrhagia as indicated by menstrual blood loss of ≥160 mL to 500 ml during one baseline cycle or two baseline cycles within three months prior to treatment
Have a history of at least 3 months of menorrhagia within the last six months
Desire uterine preservation
Do not desire current or future childbearing
Have a normal coagulation profile international normalized ratio (INR), Platelets, Prothrombin Time, and Partial Thromboplastin Time (PTT)
Have had a normal Pap smear within the past 12 months
Are practicing non-hormonal or stable hormonal contraception
If the woman is not currently taking any hormonal contraceptives, has been off all hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through the 12 months of follow-up OR
If the woman is currently taking hormonal contraceptives, has taken hormonal contraceptives for a minimum of three months prior to study enrollment, and agrees to continue without change in regimen through 12 months of follow up.**
**Note: Hormonal contraceptive use must be terminated 30 days prior to treatment but should be resumed post-operatively within 60 days post treatment as instructed by the Investigator.
Are willing and able to comply with all study tests, procedures, and assessment tools
Are willing and able to return for all required follow up visits following study enrollment
Must pass a pre-operative health exam (ASA I-III)
Are capable of providing informed consent
Exclusion criteria
Primary purpose
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137 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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