Design: Prospective, multicenter, single-arm, open label, pivotal clinical trial, with follow-up through 36 months.

Setting: Physician's Office - 5 US sites.

Patients or Participants: 114 premenopausal women with a history of heavy menstrual bleeding and a Pictorial Blood Loss Assessment (PBLAC) score >150. The demographics, mean ± SD (range), were: age 41.8 ± 4.7 (30-50) years, C-sections 0.7 ± 1.0 (0-5), sounding depth 8.6 ± 0.9 (7.0-11.0) cm, cavity length 5.2 ± 0.8 (4.0-7.8) cm, and endometrium thickness 9.5 ± 4.2 (3.0-23.4) mm.

Interventions: All 114 Minitouch Procedures were performed in office without endometrial pretreatment or period timing. Cervical dilation and cavity sealing are not required. There is no upper limit to the cavity length that can be treated.

Measurements and Main Results:

36-month data was available for 94% (107/114) of the subjects.

94% (101/107) reported eumenorrhea (normal, light, spotting or no periods), with 59% (63/107) reporting amenorrhea or spotting.

95% (98/103) of the subjects who had dysmenorrhea reported a significant reduction in their dysmenorrhea burden. Their pre-procedure score of 6.6 reduced to 0.8 on average at Month 36. 71% (76/107) reported no period pain at all at Month 36.

94% (100/107) reported no limitations at all due to menstrual periods in work, physical, social or leisure activities.

There were no device or procedure-related serious adverse events and no incidences of pregnancy. 2.6% (3/114) underwent post-procedure intervention for bleeding and other reasons.

Conclusion: The Minitouch 3.8 Era Office Endometrial Ablation procedure demonstrated a high level of safety, and effectiveness for bleeding, dysmenorrhea, and quality of life, throughout the 36 month follow up. It is performed in a physician's office without endometrial pretreatment, period timing, cervical dilation or cavity sealing.