ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)

May Health6 sites in 3 countries28 target enrollmentFebruary 14, 2019

ConditionsPolycystic Ovary Syndrome

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Polycystic Ovary Syndrome
Sponsor: May Health
Enrollment: 28
Locations: 6
Primary Endpoint: Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.
Status: Completed
Last Updated: 8 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to provide preliminary evidence for the safety and effectiveness of the May Health Kit in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Registry

clinicaltrials.gov

Start Date

February 14, 2019

End Date

August 15, 2025

Last Updated

8 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

May Health

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

Successful completion of a complete ovarian tissue ablation procedure, which is defined as achievement of the desired number of ablations within each ovary under ultrasound visualization.

Time Frame: During procedure

Adverse Events (AEs) in terms of type (device/procedure related), seriousness, level of severity. Rate of occurence of intra-procedural and post-procedural adverse events, and device related complications

Time Frame: Up to 30 days