The first successful IUD and transcervical procedures using Aspivix’s non-traumatic Carevix were performed in the U.S. This milestone underscores the potential of Carevix to offer a gentler alternative to traditional methods.
The procedures were performed by Alissa M. Conklin, MD., Assistant Professor of Clinical Obstetrics and Gynecology at Indiana University School of Medicine. She shared: “The suction was perfectly adequate and easy to use, even in a non-traditional position! CarevixTM allowed us to easily place the IUD when I otherwise could not without cervical traction.” said Dr. Conklin. “When suction was released, there was no bleeding, so we were able to immediately trim the strings and remove the speculum which makes the procedure shorter. The patient had an IUD before and said this device made her experience so much better than it was the last time!“
Dr. Conklin is part of the CarevixTM Ambassador Program, which allows OB-GYNs, midwives and nurses across 12 centers of excellence in the US, France, Sweden, Switzerland, and Germany) to use the device in routine gynecological procedures to provide a better experience for women. “This program showcases our commitment to innovation, fostering collaboration, and improving patient outcomes by refining our products in clinical practice.” explains Ikram Guerd, Managing Director US of Aspivix.
In addition to the Ambassador Program, researchers at IU School of Medicine have consented the first patient in the US for a clinical study focused on “Suction Cervical Stabilizer Compared to Standard Tenaculum for Intrauterine Procedures”. The purpose of this clinical study is to evaluate patient-reported pain, bleeding, and device efficiency along with provider satisfaction and ease of use between
intrauterine procedures employing the CarevixTM or a single-tooth tenaculum. This US clinical study complements the Swiss ADVANCE Women study, a single- blinded and randomized study, conducted in the University Hospitals of Geneva that compared the use of CarevixTM to the standard cervical tenaculum in 100 women undergoing Intrauterine Device (IUD) placement. The positive results published in Contraception show a significant reduction in pain by up to 73% and in bleeding occurrence by 78% with the CarevixTM compared to the single-tooth tenaculum for intrauterine contraceptive device insertion. This new clinical trial lead by IU School of Medicine broadens the scope of procedures among all intrauterine procedures, not only IUD insertion, including hysteroscopies, sonohysterography and endometrial biopsies.
