ASPIVIX SA, a medical technology company focused on improving gynaecological and fertility care, completed its ADVANCE Women study for Carevix, a non-traumatic, gentle approach to reduce pain and bleeding in multiple transcervical procedures, including IUD insertions. With 100 women involved in the study, Aspivix received positive results, which also got published in the health journal Contraception.
Aiming to develop modern and gentle gynecological solutions that advance women’s healthcare, Aspivix developed Carevi, an innovative, suction cervical stabilizer designed as a modern and gentler alternative to a cervical tenaculum. By leveraging suction technology to gently stabilize the cervix, Carevix delivers cervical engagement without the need to perforate the tissue. A semi-circular, anatomical pad is applied onto the delicate tissue during gynecological procedures, reducing significantly trauma associated with pain and bleeding.
The company, in collaboration with the University Hospitals of Geneva (HUG) and the University Hospital of Lausanne (CHUV), conducted the ADVANCE (Atraumatic Device using VAcuum Technology for CErvical Procedures in WOMEN) study as a single-blinded, randomized study. The trial compared the use of Carevix to the standard-of-care surgical instrument, the cervical tenaculum in 100 women undergoing Intrauterine Device (IUD) placement.
The results of the study, which was conducted at the two university hospitals, demonstrate that:
- Women in the Carevix study group reported statistically and clinically significant lower pain scores at all relevant time points during the IUD placement, with pain scores 30-53% lower with Carevix compared to tenaculum use.
- Carevix was particularly beneficial for nulliparous women, with 88% fewer nulliparous women reporting severe pain during IUD insertion in the Carevix group compared to the tenaculum group.
- Carevix led to a 78% reduction in cervix bleeding occurrence rates compared to the tenaculum.
“The IUD is more than 99% effective in preventing pregnancy and is considered the most cost-effective birth control method available, but because many women experience pain and bleeding during IUD placement, less-effective methods are chosen out of fear of procedural pain,” said Dr. Michal Yaron, investigator of the ADVANCE Women study and Head of Outpatient Gynecology Consultations, University Hospitals of Geneva. “The highly compelling results from the study demonstrate that Carevix is a promising and important alternative technology that has the potential to dramatically improve the IUD placement experience for women worldwide.”
The results have been published in the international reproductive health journal Contraception. “The publication of the ADVANCE study reinforces our commitment to offering women with clinically proven gentle solutions for gynecological and fertility needs. This publication along with the FDA clearance for Carevix, brings us one step closer to revolutionizing century-old gynecological tools and procedures,” said Mathieu Horras, Chief Executive Officer of ASPIVIX. “Our mission remains unwavering: to bring innovative technologies that prioritize women’s health and improve their lives.”
(Press release)
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