Clinical trial · Interventional
Laparoscopic Radiofrequency Ablation (RFA) of Symptomatic Uterine Fibroids
Evaluation of the Halt System for Laparoscopic Treatment of Symptomatic Uterine Fibroids With Radiofrequency Ablation
NCT00874029CI-TRIAL-00015001HaltcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
| Uterine Myomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Halt Procedure | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Halt Procedure
- description
- In this single-arm study, subjects who have symptomatic uterine fibroids will have the Halt Procedure in which intra-abdominal ultrasound will guide RF ablation of uterine fibroids using the Halt System.
- interventionNames
- Device: Halt Procedure
Primary outcomes (3)
- measure
- Assessment of Menstrual Blood Flow (MBF) at 12 Months Post Procedure
- timeFrame
- 12 months from Baseline
- description
- Change in volume of menstrual blood loss at 12 months post-procedure compared to baseline. Bleeding relief and surgical reintervention were the co-primary endpoints. Bleeding relief success was defined for individual subjects as a ≥ 50% reduction from baseline in menstrual blood loss at 12 months posttreatment. The Primary Full Analysis Set was the primary analysis set for bleeding success rate.
- measure
- Incidence of Device and Procedure-related Adverse Events Within 12 Months Post-procedure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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: * Have contraindications for laparoscopic surgery and/or general anesthesia. (Contraindications include anemia, defined as a hemoglobin level under 10 or hematocrit level less than 30.) * Have had prior pelvic surgery (with the exception of C-section, tubal ligation, or diagnostic laparoscopy), or are known to have significant intra-abdominal adhesions (defined as adhesions that would require extensive dissection to mobilize and view all surfaces of the uterus) * Have previously undergone endometrial ablation, uterine artery embolization, or uterine artery ligation, or any other uterine-preserving technique for reduction of menstrual bleeding (with the exception of hysteroscopic myomectomy \> 1 year ago) * Patients requiring elective concomitant procedures * Have contraindications for magnetic resonance imaging (MRI) * Desire current or future childbearing * Are pregnant or lactating * Have taken any Gonadotropin-releasing hormone (GnRh) agonist within three months prior to the screening procedures * Have an implanted intrauterine or fallopian tube device for contraception that cannot or will not be removed one month prior to treatment * Have dysfunctional uterine bleeding or bleeding between periods * Have chronic pelvic pain not due to uterine fibroids * Have known or suspected endometriosis * Have known or suspected adenomyosis based on Ultrasound or MRI findings * Have active or history of pelvic inflammatory disease * Have a history of or evidence of gynecologic malignancy or pre-malignancy within the past five years * Have had pelvic radiation * Have a non-uterine pelvic mass * Have a cervical myoma * Have one or more pedunculated subserosal fibroids or "type zero" (completely intracavitary) submucous fibroids * Are peri-menopausal (defined as women 40 years of age or older with Follicular Stimulating Hormone level of ≥ 25 International Units (IU) or menopausal * Are unable to give informed consent * In the medical judgment of the investigator should not participate in the study
References
Publications (6)
- RESULTChudnoff SG, Berman JM, Levine DJ, Harris M, Guido RS, Banks E. Outpatient procedure for the treatment and relief of symptomatic uterine myomas. Obstet Gynecol. 2013 May;121(5):1075-1082. doi: 10.1097/AOG.0b013e31828b7962. PMID 23635746
- RESULTRobles R, Aguirre VA, Argueta AI, Guerrero MR. Laparoscopic radiofrequency volumetric thermal ablation of uterine myomas with 12 months of follow-up. Int J Gynaecol Obstet. 2013 Jan;120(1):65-9. doi: 10.1016/j.ijgo.2012.07.023. Epub 2012 Oct 14. PMID 23073229
- RESULTGarza Leal JG, Hernandez Leon I, Castillo Saenz L, Lee BB. Laparoscopic ultrasound-guided radiofrequency volumetric thermal ablation of symptomatic uterine leiomyomas: feasibility study using the Halt 2000 Ablation System. J Minim Invasive Gynecol. 2011 May-Jun;18(3):364-71. doi: 10.1016/j.jmig.2011.02.006. PMID 21545960
- RESULTGuido RS, Macer JA, Abbott K, Falls JL, Tilley IB, Chudnoff SG. Radiofrequency volumetric thermal ablation of fibroids: a prospective, clinical analysis of two years' outcome from the Halt trial. Health Qual Life Outcomes. 2013 Aug 13;11:139. doi: 10.1186/1477-7525-11-139. PMID 23941588
- DERIVEDLevine DJ, Berman JM, Harris M, Chudnoff SG, Whaley FS, Palmer SL. Sensitivity of myoma imaging using laparoscopic ultrasound compared with magnetic resonance imaging and transvaginal ultrasound. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):770-4. doi: 10.1016/j.jmig.2013.04.015. Epub 2013 Sep 8. PMID 24021910
- DERIVEDGalen DI, Isaacson KB, Lee BB. Does menstrual bleeding decrease after ablation of intramural myomas? A retrospective study. J Minim Invasive Gynecol. 2013 Nov-Dec;20(6):830-5. doi: 10.1016/j.jmig.2013.05.007. Epub 2013 Sep 7. PMID 24018147