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Endometrial Ablation Device

Minitouch System for Menorrhagia

N/A
Waitlist Available
Led By Scott G Chudnoff, MD, MSc
Research Sponsored by MicroCube, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6 and month 12 post-procedure
Awards & highlights

Study Summary

This trial is testing a new device to help with heavy periods in premenopausal women.

Eligible Conditions
  • Heavy Menstrual Bleeding
  • Menorrhagia
  • Heavy Uterine Bleeding

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6 and month 12 post-procedure
This trial's timeline: 3 weeks for screening, Varies for treatment, and month 6 and month 12 post-procedure for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Trial Participants With Device or Procedure-related Serious Adverse Events
Number of Trial Participants With Reduction in Menstrual Bleeding (PBLAC Score of ≤75)
Secondary outcome measures
Dysmenorrhea-related Pain Score
Menorrhagia Impact Questionnaire (MIQ 2) - Limitations in Work Outside or Inside the Home
Menorrhagia Impact Questionnaire (MIQ 3) - Limitations in Physical Activity
+7 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single-Arm, Open-Label Treatment with the Minitouch SystemExperimental Treatment1 Intervention
Eligible participants will undergo a single treatment (endometrial ablation) with the Minitouch System

Find a Location

Who is running the clinical trial?

MicroCube, LLCLead Sponsor
Scott G Chudnoff, MD, MScPrincipal InvestigatorMaimonides Medical Center
Amy Brenner, MDPrincipal InvestigatorAmy Brenner, MD & Associates, LLC

Media Library

Minitouch System (Endometrial Ablation Device) Clinical Trial Eligibility Overview. Trial Name: NCT04267562 — N/A
Heavy Menstrual Bleeding Research Study Groups: Single-Arm, Open-Label Treatment with the Minitouch System
Heavy Menstrual Bleeding Clinical Trial 2023: Minitouch System Highlights & Side Effects. Trial Name: NCT04267562 — N/A
Minitouch System (Endometrial Ablation Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04267562 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does my profile correspond to the requirements of this trial?

"This trial is looking to enrol 114 individuals aged between 30 and 50 who suffer from menorrhagia. Furthermore, they must have a PBLAC score of at least 150 during the screening cycle and display prior evidence of excessive menstrual bleeding. The uterine cavity length should also be no shorter than 4 centimeters. Lastly, participants need to agree to use reliable contraception for three months before treatment or abstain from hormonal birth control for 12-months after treatment if not doing so previously."

Answered by AI

What results is the clinical trial hoping to accomplish?

"This clinical trial involves a 12-month follow up to evaluate its effectiveness. The primary outcome is the Clinical change in menstrual blood loss and secondary measures include Amenorrhea rates, Change in quality of life measured by Menorrhagia Impact Questionnaire (MIQ) and Dysmenorrhea-related Numerical Rating Scale (NRS)."

Answered by AI

Is the opportunity to join this experiment currently available?

"This clinical trial is not currently open for recruitment, as it was posted on February 28th 2020 and last updated August 22nd 2022. Nonetheless, there are 378 similar studies actively searching for subjects at the present moment."

Answered by AI

Is the age criteria for participation in this trial limited to those over 70 years old?

"As outlined in the inclusion criteria, individuals aged 30 to 50 years old can partake in this medical trial."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness
2020. "Minitouch Endometrial Ablation System Treatment for Menorrhagia: An Evaluation of Safety & Effectiveness". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04267562.
~43 spots leftby Apr 2025
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