ULTRA Study - Version 1, August 7th, 2018

• Research type

  Research Study

• Full title

  ULTRA Study: a feasibility, prospective, multicenter, single-arm Trial of the AblaCare Device in Transvaginal Ablation of Ovarian Tissue under Ultrasound Visualization in Women with Infertility Due to Polycystic Ovary Syndrome

• IRAS ID

  252912

• Contact name

  Saad Amer

• Contact email

  saad.amer@nhs.net

• ISRCTN Number

  ISRCTN00000000

• Clinicaltrials.gov Identifier

  NCT00000000

• Clinicaltrials.gov Identifier

  N/A, N/A

• Duration of Study in the UK

  1 years, 9 months, 1 days

• Research summary

  The purpose of the ULTRA Study is to demonstrate the safety and effectiveness of the AblaCare Device in transvaginal ablation of ovarian tissue under ultrasound visualization in women with infertility due to polycystic ovary syndrome. This will be the first clinical investigation on the AblaCare Device in humans on 30 patients and the resulting data will be used for CE marking. At present, the device is not registered or placed on the market in any state or region.

• REC name

  South East Scotland REC 02

• REC reference

  18/SS/0119

• Date of REC Opinion

  17 Oct 2018

• REC opinion

  Further Information Favourable Opinion