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Clinically Proven: A Rigorous FDA-Approved Trial

Minitouch was evaluated in a rigorous, U.S. FDA-approved clinical trial to ensure its safety, effectiveness, and long-term patient outcomes. The trial confirmed that Minitouch delivers exceptional results in reducing heavy menstrual bleeding and period pain, with a high safety profile and minimal need for reintervention.

Protocol Summary

The Minitouch FDA trial was conducted under strict clinical protocols to assess safety, efficacy, and patient satisfaction.

Multicenter, prospective study across leading U.S. gynecological centers
Standardized endometrial ablation technique using Minitouch’s low-temperature energy delivery
Follow-up at 3, 12, 24, and 36 months to track long-term outcomes
Primary endpoints: Reduction in menstrual bleeding and improvement in quality of life
Secondary endpoints: Safety, patient satisfaction, and reintervention rates

This study validated Minitouch as an effective, minimally invasive alternative to hysterectomy and second-generation ablation devices.

Patient Demographics

Minitouch was tested in a diverse patient population, ensuring broad applicability across different backgrounds and medical histories.

The trial confirmed that Minitouch delivers consistent success across all demographic groups, regardless of prior medical history.

Women aged 30-55

experiencing heavy menstrual bleeding

Patients with prior C-sections included

confirming safety for post-surgical uterine tissue

Diverse uterine sizes and shapes

tested to ensure effectiveness in a broad patient pool

Patients contraindicated

for general anesthesia were included, proving suitability for in-office procedures

Minitouch’s FDA trial demonstrated superior safety,

efficacy, and long-term patient satisfaction. Backed by rigorous clinical validation, it is the new standard in in-office endometrial ablation.