Journal of minimally invasive gynecology · 2015
One-Year Follow-Up Results of a Multicenter, Single-Arm, Objective Performance Criteria-Controlled International Clinical Study of the Safety and Efficacy of the Minerva Endometrial Ablation System.
Clinical StudyСтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Laberge Philippe, Garza-Leal Jose, Fortin Claude, Sabbah Robert, Fulop Tamas, Pásztor Norbert, Bacsko György
Аннотация
STUDY OBJECTIVE: To assess the safety and effectiveness of the Minerva endometrial ablation system for treating excessive uterine bleeding in premenopausal women.
DESIGN: Multicenter, single-arm, objective performance criteria (OPC)-controlled international study (Canadian Task Force classification II-1).
SETTING: Seven academic medical centers.
PATIENTS: 105 premenopausal women symptomatic for menorrhagia secondary to dysfunctional uterine bleeding.
INTERVENTION: Patients were treated using the Minerva endometrial ablation system.
MEASUREMENTS AND MAIN RESULTS: Study success, based on a pictorial blood loss assessment chart (PBLAC) score ≤75, was observed in 96.2% of the patients at 1 year posttreatment. Some 69.5% of the patients experienced amenorrhea (PBLAC score 0). The mean duration of the procedure was 3.9 minutes. General anesthesia was used in 9% of cases, with the balance being performed under local and/or intravenous or spinal anesthesia regimens. No intraoperative adverse events and/or complications were reported. No patient required hysterectomy or any additional medical and/or surgical interventions to control bleeding during 1 year of follow-up. Efficacy (success) results were compared between the Minerva system and the OPC, which served as a statistical control. The OPC comprised the US Food and Drug Administration's (FDA) reported success rates of all FDA-approved endometrial ablation systems. The Minerva system had a statistically significantly superior success rate compared with the OPC control.
CONCLUSION: The Minerva system was found to be safe and effective for treating patients suffering from menorrhagia. The procedure is quick and effective, does not require endometrial pretreatment, and precludes the need for additional surgical interventions to manage menorrhagia.
DESIGN: Multicenter, single-arm, objective performance criteria (OPC)-controlled international study (Canadian Task Force classification II-1).
SETTING: Seven academic medical centers.
PATIENTS: 105 premenopausal women symptomatic for menorrhagia secondary to dysfunctional uterine bleeding.
INTERVENTION: Patients were treated using the Minerva endometrial ablation system.
MEASUREMENTS AND MAIN RESULTS: Study success, based on a pictorial blood loss assessment chart (PBLAC) score ≤75, was observed in 96.2% of the patients at 1 year posttreatment. Some 69.5% of the patients experienced amenorrhea (PBLAC score 0). The mean duration of the procedure was 3.9 minutes. General anesthesia was used in 9% of cases, with the balance being performed under local and/or intravenous or spinal anesthesia regimens. No intraoperative adverse events and/or complications were reported. No patient required hysterectomy or any additional medical and/or surgical interventions to control bleeding during 1 year of follow-up. Efficacy (success) results were compared between the Minerva system and the OPC, which served as a statistical control. The OPC comprised the US Food and Drug Administration's (FDA) reported success rates of all FDA-approved endometrial ablation systems. The Minerva system had a statistically significantly superior success rate compared with the OPC control.
CONCLUSION: The Minerva system was found to be safe and effective for treating patients suffering from menorrhagia. The procedure is quick and effective, does not require endometrial pretreatment, and precludes the need for additional surgical interventions to manage menorrhagia.