80 million women are affected by the tenaculum every year
in common office based gynecological procedures.
- Almost 90% of women report moderately to severe pain during procedures using a tenaculum. 1
- 18% of European women in reproductive age, report that fear of pain is main reason for not selecting an IUD as their contraceptive method. 2
The Intrauterine Contraceptive Device (IUD) is 99% effective in preventing pregnancies and is considered the most cost-effective birth control method available today.
But what triggers the pain?
For procedures that require access to the uterus, gynecologists insert the tenaculum into the vagina, and pierce the cervix’s tissue to grab, stabilize and pull it steadily.
Such procedures are often carried out without anesthesia.
Dr. Martin Winkler – well-known for his many articles on Women’s Health – describes the tenaculum as a «butcher’s hook», that can make holes in the cervix.
While the tenaculum is highly effective because it provides a firm and strong hold of the cervix, it often causes pain and bleeding.
This undesirable experience discourage clinicians from recommending and women from adopting the Intrauterine Contraceptive Device (IUD).
The IUD is considered the goal standard in contraception because it is 99% effective in preventing pregnancy.
- Interventions for pain with intrauterine device insertion
- Data on File. Internal Aspivix Survey with 500 European Women
Gentle. Simple. Intuitive.
Carevix has been carefully designed and developed in closed collaboration with gynecologists, nurses and midwives as well as female patients.
The result is a women-friendly cervical device that uses a delicate suction technology to secure the cervix, with patient’s comfort always in mind and without compromising on performance.
Carevix Suction Cervical Device delivers cervical engagement with the same maneuverability as the traditional tenaculum but without the need to perforate the tissue.
Early results for our First in Women Phase-I trial are promising. Women undergoing IUD procedures experienced low or no pain and no bleeding. (press release)
The First in Women Phase-II, a comparative randomized trial, is currently underway in Switzerland, at the Lausanne and Geneva University Hospitals (CHUV and HUG). The results from this trial are expected in August 2021.
What Clinicians are Saying
Dr. Helene Legardeur
Gynecologist at CHUV, Investigator Aspivix First in Women Trial
“I fully enjoyed testing the novel Aspivix device for cervix stabilization during IUD insertion procedures. The device seems to be valued by female patients as it is atraumatic and significantly reduce pain. A larger clinical study to demonstrate its benefits in comparison with the gold standard is underway”.
Prof. Patrice Mathevet
Chief Gynecologist at CHUV, Principal Investigator Aspivix First in Women Trial
“The IUD is considered the most cost-effective contraceptive, but many women experience pain and bleeding during insertion related to the tenaculum, a forceps-like surgical instrument used in the procedure. The innovative Carevix device is easy-to-use, and I am encouraged by its potential to enhance women’s overall experience during IUD placement.”
Dr. Ursula Nadig
Gynecologist at Private Practice in Zurich
“Throughout my career in gynecology, I have always tried my best to make my female patients comfortable during routine procedures. The simplicity of the Carevix device and its ingenuity makes me wonder why did we have to wait so long? I look forward to using this new device in my practice, with my female patients.”