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

NCT05320289 | Completed FDA Device

• 1 other identifier: ULTRA-US
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

PCOS; Infertility related to PCOS; Ovulation restoration

Outcome Measures

Primary Outcomes (1)

• Occurrence of at least one (1) ovulation between treatment and 3-month visit.

  3 months

Secondary Outcomes (2)

• Occurrence of at least one (1) ovulation between treatment and the 6-month visit with or without 1st line medication 3 months or more post-procedure

  6 months

• 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.

  During procedure

Other Outcomes (25)

• Pain level after procedure completion measured by a Visual Analog Scale (VAS) from 0 (no pain) to 10 (worst pain)

  Immediately after procedure completion, at 7-day and at 30-day follow up

• Pain medication taken during procedure and after procedure

  During procedure, at 7-day and at 30-day follow up

• Documented ovulation

  Between week 2 and week 24 post-procedure

Study Arms (1)

AblaCare Procedure

EXPERIMENTAL

AblaCare Procedure performed with use of the AblaCare Kit intended for transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome.

Device: AblaCare System

Interventions

AblaCare System DEVICE

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.

AblaCare Procedure

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age: ≥ 18 to ≤ 40 years
• Diagnosis of Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria: Infertility associated with chronic anovulation or oligomenorrhea, AND EITHER:
• Ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or ovarian antral follicle count per ovary ≥ 20) OR 2.2. Evidence of hyperandrogenaemia: either clinical (hirsutism defined as mFG level ≥ 4-6 depending on ethnicity) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI \> 4)
• At least one ovary with ovarian volume ≥ 10ml
• Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
• Failure to respond to first-line pharmacological treatment or is contraindicated for or decline such treatment.
• At least one patent fallopian tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
• Willing to comply with Clinical Investigation Plan-specified follow-up evaluation
• Ability to understand study requirements and has sufficient fluency in one of the IRB-approved written translation of the Patient Information and Informed consent form
• Signed informed consent
• Normal sperm parameters based on WHO 2010 criteria (concentration ≥ 15 million/mL, total motility ≥ 40%, normal morphology ≥ 4%) within the last year
• Ability to have regular vaginal intercourse during the study
• No previous sterilization procedures (vasectomy, tubal ligation) that have been reversed

You may not qualify if:

• Current pregnancy
• Marked obesity, BMI \> 40
• Marked hyperandrogenism (FAI \> 15)
• Patient is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
• Patient not willing to stop all concomitant first-line oral medications at least 6 weeks prior to study procedure and until the 3-month endpoint is reached, and all other forms of ovulation-induction treatment until the 6-month endpoint is reached
• Lack of capacity to give informed consent
• Lack of capacity to follow Clinical Investigation Plan and study requirements including all study follow-up visits
• Previous ovarian surgery: laparoscopic ovarian drilling, endometriosis surgery, ovarian cysts surgery
• Patient with known or suspected periovarian adhesions
• Transvaginal ultrasound transducer cannot be brought into proximity of both ovaries

Sponsors & Collaborators

• May Health: lead

Study Sites (1)

University of Oklahoma

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility, Female

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Infertility

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2022
• First Posted: April 11, 2022
• Study Start: May 12, 2022
• Primary Completion: November 15, 2022
• Study Completion: October 11, 2023
• Last Updated: November 9, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)