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clinical data show significantly lower iud procedural pain and bleeding rates with aspivix's novel SUCTION-BASED...

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Benzinga
By Pr Newswire

GHENT, Belgium, May 25, 2024 /PRNewswire/ -- ASPIVIX SA, a developer of medical technologies to advance gynecological care, today announced positive results from its ADVANCE Women (Atraumatic Device using VAcuum Technology for CErvical Procedures in Women) study. The data confirm the usability, efficacy, and safety of CarevixTM, an innovative, soft-suction cervical device designed as a modern and gentler alternative to a tenaculum to stabilize the cervix for the insertion of an Intrauterine Device (IUD) for contraception.

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ADVANCE Women is a single-blinded, randomized, comparative study of 100 women who underwent IUD insertion with either the Carevixdevice or a tenaculum, the forceps-like, standard-of-care surgical instrument. Results from the study, conducted at Geneva University Hospitals (HUG) and Lausanne University Hospital (CHUV), were shared at the 16th Congress of the European Society of Contraception and Reproductive Health:

  • Women in the Carevix study arm reported significantly lower pain scores at all relevant points of the IUD procedure. Pain scores were 52% lower with the Carevix device during cervix grasping, 53% lower during cervix stabilization (traction), 30% lower during IUD insertion, and 33% lower during cervix release, compared to tenaculum use.
  • Women who had not given birth (nulliparous), experienced the greatest benefits from Carevix. During IUD insertion, twice as many nulliparouswomenin the Carevix group were free of pain compared to those in the tenaculum group, and they reported an 88% lower rate of severe pain.
  • Bleeding rates were 78% lower with Carevix vs. the tenaculum.

The IUD is 99% effective in preventing pregnancies and is considered the most cost-effective birth control method available, but many women experience pain and bleeding during IUD placement, leading to the use of less effective methods out of fear of procedural pain, said Dr. Michal Yaron, ADVANCE Women investigator and Head of Outpatient Gynecology Consultations, Department of Woman, Child & Adolescent, Geneva University Hospitals. The highly compelling results from the ADVANCE Women study demonstrate that Carevixis a promising and important alternative technology that has the potential to dramatically improve the IUD placement experience for women around the world.

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