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Clinical evidence

 

News Title

Womed is committed to evidence-based medicine and is investing in clinical research to demonstrate the medical value of its products and establish them as new standards of care.

Womed Leaf clinical program

Womed Leaf's clinical evaluation is part of a large ongoing study program. The program aims to bring solid scientific evidence to the ObGyn community and benefit women in their fertility projects. It is designed in phases:


  • PREG1: European study to validate safety after hysteroscopic myomectomy


  • PREG2: International study to evaluate efficacy after adhesiolysis ​​

PREG1 clinical study

PREG1 (NCT04381728) is a prospective, multi-center, single arm clinical study that aims to evaluate the safety of Womed Leaf after hysteroscopic myomectomy and its efficacy in preventing intrauterine adhesions at second look hysteroscopy.

Target population: Women with one or more myoma(s), who qualify for hysteroscopic myomectomy

 

Co primary endpoints

  • Safety endpoint: number and type of device-related adverse events (AE) up to 30 days:

    • Per-operative AEs during device use (cervical trauma, uterine perforation…)

    • Polymer film tolerance defined as fever, pain or bleeding between 48 hours post procedure and 30 days

  • Efficacy endpoint: freedom from intrauterine adhesion at second look hysteroscopy between 4 and 8 weeks, and evaluation of severity according to American Fertility Society (AFS) and European Society of Gynecological Endoscopy classifications systems of intrauterine adhesions.

 

Follow-up assessments

  • 2 hours after the procedure : 2D or 3D ultrasound in order to visualize the polymer position and swelling in the uterine cavity. 

  • 30 days post procedure : all subjects are contacted by phone call to assess their clinical status and adverse events.

  • At 4 to 8 weeks: All subjects will undergo “second look” hysteroscopy.

7 centers in 3 countries are participating. ​

Results are expected early 2021.

References

  • Review of intrauterine adhesion prevention and treatment - Warembourg et al. (2015)

  • A new bioabsorbable polymer film to prevent peritoneal adhesions validated in a post-surgical animal model - Allègre et al. (2018) 

  • Preliminary design of a new degradable medical device to prevent the formation and recurrence of intrauterine adhesions - Leprince et al. (2019) 

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