The primary effectiveness endpoint is a clinical change in menstrual blood loss as assessed by the Pictorial Blood Loss Assessment Chart (PBLAC) data, a validated, patient self-reported menstrual diary scoring system. Success for the primary effectiveness endpoint was defined as reduction in menstrual bleeding to a PBLAC (Pictorial Blood Loss Assessment Chart) score of ≤75.

Scale information for PBLAC (Pictorial Blood Loss Assessment Chart):

The scale minimum is 0, which indicates amenorrhea, i.e., no bleeding. There is no scale maximum. A score of 100 indicates eumenorrhea, i.e., normal menstrual bleeding. A lower PBLAC score indicates less bleeding and a higher PBLAC score indicates more bleeding.

The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

The primary safety endpoint is the incidence of device or procedure-related serious adverse events.

The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.

The Intent-to-Treat (ITT) Analysis Cohort is comprised of all subjects who met all Trial eligibility criteria and in whom the procedure was initiated.

Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Dysmenorrhea-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2):

Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2):

Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 2):

Subjects were asked if they had any limitations in work outside or inside the home based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3):

Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3):

Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 3):

Subjects were asked if they had any limitations in physical activity based on the following categories: not at all, slightly, moderately, quite a bit, extremelylimitations in social and leisure activities: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4):

Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4):

Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Change in quality of life as measured by Menorrhagia Impact Questionnaire (MIQ 4):

Subjects were asked if they had any limitations in social or leisure activities based on the following categories: not at all, slightly, moderately, quite a bit, extremely

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Secondary Outcome Measure - Use of Cervical Dilator (Yes / No) Time frame: the need for using a cervical dilator is assessed on day of procedure, during the procedure

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Secondary Outcome Measure - Setting in which the Minitouch Procedure took place Time frame: the type of setting is assessed on day of procedure, prior to the procedure

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Procedure-related pain score using the Numerical Rating Scale (NRS) (scale of minimum 0 to maximum 10, where 0 = no pain, 5 = moderate pain, 10 = worst pain). A higher score indicates a worse outcome.

Timepoints:

Pre-procedure (on the day of, prior to the procedure) Discharge (post-procedure, prior to discharge) 24-hours post-procedure (18-48 hours post-procedure)

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Secondary Outcome Measure - Total Procedure Recovery Time Time frame: assessed on the day of procedure/post-procedure, prior to discharge

The Per Protocol (PP) Analysis Cohort is comprised of all Intent-to-Treat (ITT) subjects who are treatable, completed the ablation procedure, and attended the 12-month follow-up visit.

Count of subject self-report of pregnancy at Month 36 to satisfy the post-approval study (PAS) reporting requirements

Count of subject contraception menthods reported at Month 36 to satisfy the post-approval study (PAS) reporting requirements; subjects could report more than one method of contraception so numbers may be greater than the total of subjects

Count of number of subjects that reported gynecologic adverse events through Month 24 and Month 36;