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A Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS Infertility

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ClinicalTrials.gov Identifier: NCT03760926
Recruitment Status : Recruiting
First Posted : December 3, 2018
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
AblaCare

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

Condition or disease Intervention/treatment Phase
Polycystic Ovary Syndrome Device: AblaCare Kit Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: ULTRA Study: a Feasibility, Prospective, Multicenter, Single-arm Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualisation in Women With Polycystic Ovary Syndrome (PCOS)
Actual Study Start Date : February 14, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2023

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Arms and Interventions
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Arm Intervention/treatment
Experimental: AblaCare Procedure
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 Kit
The intervention consists in the realisation of the AblaCare Procedure using the AblaCare Kit, which comprises two elements: a disposable device (AblaCare Device) and a radiofrequency (RF) energy generator (AblaCare System). The AblaCare Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Secondary Outcome Measures :
  1. Occurrence of ovulation following the procedure [ Time Frame: Up to 3 months after procedure ]

Other Outcome Measures:
  1. Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered during procedure [ Time Frame: At procedure, 7 days, 30 days ]
  2. Usability of the AblaCare Kit [ Time Frame: During procedure ]
  3. Pain level using the Visual Analogue Scale (VAS - 0 : no pain - 10 : worse pain possible), record of pain medications with doses administered post-procedure [ Time Frame: At 30 days ]
  4. AblaCare Procedure time [ Time Frame: During procedure ]
  5. Occurrence of ovulation following the procedure [ Time Frame: Up to 6 months after procedure ]
  6. Pregnancy [ Time Frame: At 3, 6, 9 12 and 24 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Candidates for this study must meet ALL of the following criteria:

Inclusion criteria for female participants:

  • Anovulatory infertility associated with PCOS
  • Age: ≥ 18 to ≤ 40 years
  • Diagnostic transvaginal ultrasound to validate ultrasonographic evidence of PCOS (ovarian volume ≥ 10ml and/or follicle number per ovary of ≥ 20)
  • Ovarian accessibility: determined by ability to bring transvaginal ultrasound transducer into close proximity to ovaries
  • Evidence of hyperandrogenaemia: either clinical (hirsutism or acne) or biochemical (raised serum concentration of androgens (testosterone ≥ 2.5nmol/l, or FAI > 4)

  • Failure of first-line pharmacological treatment defined as:

    • failure to ovulate on highest dose of first line pharmacological treatment, OR
    • failure to conceive on appropriate dose of first line pharmacological treatment for at least six cycles, OR
    • discontinuation of first-line pharmacological treatment due to side-effects.
  • At least one patent tube and normal uterine cavity as determined by sonohysterogram, hysterosalpingogram, or hysteroscopy/laparoscopy within the last 3 years
  • Willing to comply with protocol-specified follow-up evaluation
  • Signed informed consent

Couple inclusion criteria:

  • Normal sperm parameters based on WHO 2000 criteria (concentration⩾ 15 million/mL, motility A+B ⩾ 32%, normal forms ⩾ 4%).
  • No previous sterilization procedures

Candidates will be excluded from the study if ANY of the following conditions apply:

  • Current pregnancy
  • Marked obesity, BMI > 35
  • Marked hyperandrogenism (FAI > 15)
  • Subject is currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study
  • Lack of capacity to give informed consent
  • Previous ovarian surgery: LOD, endometriosis surgery, ovarian cysts surgery, patients with known or suspected periovarian adhesions.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03760926


Locations
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United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom, DE22 3NE
Contact: Lianne Hufton    00441332788608    lianne.hufton1@nhs.net   
Royal Hallamshire Hospital Recruiting
Sheffield, United Kingdom, S10 2JF
Contact: Elizabeth Taylor    00441142268050    liz.taylor15@nhs.net   
Sponsors and Collaborators
AblaCare
More Information
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Responsible Party: AblaCare
ClinicalTrials.gov Identifier: NCT03760926    
Other Study ID Numbers: ULTRA
First Posted: December 3, 2018    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AblaCare:
Anovulatory infertility
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Syndrome
Disease
Pathologic Processes
Genital Diseases, Female
Ovarian Cysts
 Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases