Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome

NACompletedINTERVENTIONAL
Enrollment

5

Participants

Timeline

Start Date

May 12, 2022

Primary Completion Date

November 15, 2022

Study Completion Date

October 11, 2023

Conditions
Polycystic Ovary SyndromeInfertility, Female
Interventions
DEVICE

AblaCare System

"The intervention includes the short-term use of the AblaCare System, which is comprised of three elements: (1) the AblaCare Needle-Catheter Ablation Device (NCAD) (the Device) a 16G echogenic needle including a bipolar temperature-controlled RF ablation catheter which is clipped and secure onto a vaginal ultrasound probe; (2) the AblaCare Adapter which is clipped onto the ultrasound probe; and (3) the AblaCare Generator: a bipolar radiofrequency (RF) ablation platform utilizing the single use AblaCare NCAD for ovarian tissue ablation.~Once th patient is under conscious sedation, the physician guides the AblaCare system transvaginally with the use of a transvaginal ultrasound. Once the AblaCare device is safely and securely positioned, the physician will deliver radio frequency energy inside the ovary in order to ablate the tissue."

Trial Locations (1)

73104

University of Oklahoma, Oklahoma City

Sponsors

Lead Sponsor

All Listed Sponsors
lead

May Health

INDUSTRY

NCT05320289 - Feasibility Study of the AblaCare System in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With Infertility Due to Polycystic Ovary Syndrome | Biotech Hunter | Biotech Hunter