Design: 114 subjects underwent the Minitouch Office Procedure in a prospective, multicenter, single-arm, open label, pivotal clinical trial. Their dysmenorrhea NRS scores (scale 0 to 10) were collected pre-procedure, and at 3, 6, 12, 24 and 36 months post-procedure.

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:

Mean NRS score was 6.1 pre-procedure. It reduced to 1.4, 0.9, 08, 1.0 and 0.9 respectively at 3, 6, 12, 24 and 36 months.

At 36 months, 71% (76/107) of the subjects reported a score of zero (0) indicating no pain at all. 95% (98/103) who had dysmenorrhea saw their mean score reduced from 6.6 to 0.8. For 6% (6/107), the individual scores remained the same. Their scores were zero or low with a mean of 1.0. For 3% (3/107), the mean score increased slightly from 2.3 to 4.7.

Conclusion: The Minitouch Office Procedure delivered a significant reduction in dysmenorrhea burden for 95% of the subjects. The improvement was reported as early as at 3 months and remained consistent through the 36-month endpoint.