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Procedure
AblaCare System for Polycystic Ovary Syndrome (ULTRA-US Trial)
N/A
Waitlist Available
Research Sponsored by May Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing the safety and effectiveness of the AblaCare System, a device that helps doctors remove small parts of the ovary using ultrasound, in women with PCOS who have trouble getting pregnant and haven't had success with other treatments.
Eligible Conditions
- Polycystic Ovary Syndrome
- Female Infertility
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: AblaCare ProcedureExperimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
AblaCare System
2022
N/A
~10
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Who is running the clinical trial?
May HealthLead Sponsor
2 Previous Clinical Trials
223 Total Patients Enrolled
2 Trials studying Polycystic Ovary Syndrome
223 Patients Enrolled for Polycystic Ovary Syndrome
AblaCareLead Sponsor
1 Previous Clinical Trials
28 Total Patients Enrolled
1 Trials studying Polycystic Ovary Syndrome
28 Patients Enrolled for Polycystic Ovary Syndrome
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with Polycystic Ovary Syndrome (PCOS) based on certain symptoms, such as irregular periods or difficulty getting pregnant.You did not respond to initial medication treatment or cannot receive it for medical reasons or personal choice.You are able to have regular sexual intercourse through the vagina during the study.You have known or suspected adhesions around the ovaries.
Research Study Groups:
This trial has the following groups:- Group 1: AblaCare Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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