Adults 30 to 50, female only, with Menorrhagia or Heavy Menstrual Bleeding. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)Primary· Month 12 post-procedure
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 men
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
102
Number of Trial Participants With Device or Procedure-related Serious Adverse EventsPrimary· Month 12 post-procedure
The primary safety endpoint is the incidence of device or procedure-related serious adverse events.
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
0
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal BleedingSecondary· Month 12 post-procedure
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
0
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal BleedingSecondary· >Month 12 through Month 24 post-procedure
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
2
Number of Trial Participants That Underwent Subsequent Medical or Surgical Intervention to Treat Abnormal BleedingSecondary· >Month 24 through Month 36 post-procedure
Secondary safety outcome measures are the number of trial participants that underwent medical or surgical intervention to treat abnormal bleeding.
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
1
Number of Trial Participants With AmenorrheaSecondary· Month 6 and Month 12 post-procedure
Secondary Effectiveness Outcome Measure - Amenorrhea rates where PBLAC = 0 (no bleeding)
Month 6
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
50
Month 12
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
59
Number of Trial Participants With AmenorrheaSecondary· Month 24 post-procedure
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
49
Number of Trial Participants With AmenorrheaSecondary· Month 36 post-procedure
Secondary Effectiveness Outcome Measure - Amenorrhea rates per the Investigator Global Evaluation (IGE)
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
48
Dysmenorrhea-related Pain ScoreSecondary· Baseline, Month 6 and Month 12 post-procedure
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.
Baseline
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
6.1
± 2.6
Month 6
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
0.9
± 1.5
Month 12
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
0.8
± 1.5
Dysmenorrhea-related Pain ScoreSecondary· Baseline and Month 24 post-procedure
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.
Baseline
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
6.2
± 2.6
Month 24
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
1.0
± 1.8
Dysmenorrhea-related Pain ScoreSecondary· Baseline and Month 36 post-procedure
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.
Baseline
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
6.2
± 2.6
Month 36
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
0.9
± 1.7
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the HomeSecondary· Baseline, Month 6 and Month 12 post-procedure
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
Baseline
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
9
Single-Arm, Open-Label Treatment With the Minitouch System
17
Single-Arm, Open-Label Treatment With the Minitouch System
34
Single-Arm, Open-Label Treatment With the Minitouch System
34
Month 6
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
105
Single-Arm, Open-Label Treatment With the Minitouch System
7
Single-Arm, Open-Label Treatment With the Minitouch System
2
Single-Arm, Open-Label Treatment With the Minitouch System
0
Month 12
Group
Value
95% CI
Single-Arm, Open-Label Treatment With the Minitouch System
108
Single-Arm, Open-Label Treatment With the Minitouch System
3
Single-Arm, Open-Label Treatment With the Minitouch System
3
Single-Arm, Open-Label Treatment With the Minitouch System
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Month 36 post-procedure.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Single-Arm, Open-Label Treatment With the Minitouch System
Serious: 3/114 (3%)
Deaths: 0/114
Serious adverse events (4 terms)
Reaction
System
Single-Arm, Open-Label Tre…
Atrial fibrillation
Cardiac disorders
—
COVID-19 pneumonia
Infections and infestations
—
Spinal compression fracture
Injury, poisoning and procedural complications
—
Syncope
Nervous system disorders
—
Other adverse events (110 terms — click to expand)
The EASE Clinical Trial is prospective, multi-center, single-arm (open-label), non-randomized, clinical trial to evaluate the Minitouch Endometrial Ablation System ("Minitouch System") in premenopausal women with menorrhagia.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by MicroCube, LLC
Last refreshed: 18 November 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04267562.