NCT06397885

Prospective on Market Patient-reported Outcomes for Milli

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Materna Medical · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the effectiveness of the Milli device in achieving vaginal intercourse

Detailed description

The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion. This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device. The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement: The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex. .

Conditions

• Vaginismus
• Dyspareunia

Interventions

Type	Name	Description
DEVICE	Milli Vaginal Dilator	Patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion

Timeline

• Start date: 2024-05-12
• Primary completion: 2025-11-30
• Completion: 2025-12-30
• First posted: 2024-05-03
• Last updated: 2024-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study