Aspivix announced first gynaecological procedures performed in the US
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The Biopôle-based startup announced a groundbreaking achievement in the United States with the first patients benefiting from successful IUD placement and transcervical procedures using its innovative cervical device.
The first patients in the United States with successful procedures
The first gentle procedures were successfully performed by Alissa M. Conklin, MD. an Assistant Professor of Clinical Obstetrics and Gynaecology at Indiana University School of Medicine.
Dr. Conklin said the procedures were conducted with ease and provided excellent suction and traction, allowing adequate access without difficulties. The patient reported significantly less pain and no bleeding compared to previous procedures involving traditional tenaculum use.
“The suction was perfectly adequate and easy to use, even in a non-traditional position! Carevix™ 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!“.
“It was preferable to prior IUD placement because there was essentially no pain!” shared the first patient satisfied by the procedure that felt more comfortable. “I’m glad research to lessen women’s pain is being conducted!”. Another patient shared “Dr. Conklin also explained that the common tool has been around for a while, so knowing this design of the old tool vs the newer one made me feel like I made the right choice.”
New clinical study in the United States to improve women’s health
In addition to the Ambassador Program, researchers at IU School of Medicine have consented the first patient in the nation for a clinical study focused on “Suction Cervical Stabiliser 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 Carevix™ 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 Carevix™ 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 Carevix™ compared to the single-tooth tenaculum for intrauterine contraceptive device insertion (1).
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.
Source: press release