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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: May Health · Industry
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to provide preliminary evidence for the safety and effectiveness of the AblaCare System in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome (PCOS) who have not responded to first-line ovulation induction treatment or are contraindicated for or decline such treatment.

Conditions

• Polycystic Ovary Syndrome
• Infertility, Female

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-05-12
• Primary completion: 2022-11-15
• Completion: 2023-10-11
• First posted: 2022-04-11
• Last updated: 2023-11-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study