The tenaculum is a gynecological instrument over a century old, created during the Civil War by Dr. Samuel-Jean Pozzi. Inspired by a forcep bullet extractor used on the battlefield, Pozzi mimicked the shape of the tool to create the “Pozzi forcep”, now known as the modern-day tenaculum^[4]. This instrument, with its pointed teeth-like ends, is utilized in gynecological procedures to stabilize the cervix. Since the teeth pierce through the cervical tissue, 89% of women experience severe pain when undergoing tenaculum-based traction.^[1] Despite developing different techniques for tenaculum stabilization, studies found neither attempted solution reduces pain by a significant amount^[3]. Dr. Martin Winkler even compared the tenaculum to a “butcher’s hook”(2022). Women should not have to suffer due to outdated medical practices while living in the age of modern technology. 

This is why Aspivix reimagined the tenaculum with an innovative, atraumatic device: the Carevix^TM. This device replaces the sharp teeth of a tenaculum with a much friendlier semi-circular, vacuum-like head. Soft-suction technology allows for cervical engagement without painfully perforating the tissue during various transcervical procedures (e.g. intrauterine device insertion, hysteroscopy, and fertility procedures).^[1]

Aspivix conducted a randomized controlled trial involving 100 Swiss women at Geneva University Hospitals and Lausanne University Hospital to compare the Carevix^TM to the tenaculum during an IUD insertion.^[2] This clinical trial measured the practitioner’s perspective on the usability and efficacy, the patient’s sense of pain at different points throughout the insertion, the number of placement attempts and spontaneous releases, and an assessment of bleeding or other adverse events.^[5] Results showed that women reported significantly lower pain levels when using the Carevix.^TM Specifically, 52% less pain during cervix grasping, 53% less during cervix stabilization, 30% less during IUD insertion, and 33% less during cervix release. Overall, rates of bleeding subsequent to the procedure decreased by 78%.^[2] Aspivix’s study was shared at the 16th Congress of the European Society of Contraception and Reproductive Health and the Carevix^TM is now FDA-Cleared for the U.S. market and authorized in the UK. 

The practice of gynecology is historically rooted in racist and misogynistic experiments. The continuation of unnecessary procedures that discomfort the patient acts as a barrier to accessing healthcare. Out of women who choose against getting an IUD, 18% report the fear of pain as their reason for refusal.^[4] In order to achieve healthcare equity, it is necessary to emphasize the importance of medical innovation and revision. We can support medical research by making monetary contributions, participating in clinical trials, and spreading education and awareness.

References

[1] “CarevixTM”. (2023). Aspivix. Retrieved Jan 2, 2024, from https://www.aspivix.com/ 

[2] “Clinical data show significantly lower IUD procedural pain and bleeding rates with aspivix’s novel suction-based cervical device”. (2022, May 25,). PR Newswire. Retrieved Jan 2, 2024, from https://www.prnewswire.com/news-releases/clinical-data 

show-significantly-lower-iud-procedural-pain-and-bleeding-rates-with-aspivixs-novel-suction-ba sed-cervical-device-301554868.html?tc=eml_cleartime 

[3] Lambert, T., Truong, T., & Gray, B. (2019). Pain perception with cervical tenaculum placement during intrauterine device insertion: A randomised controlled trial. BMJ. https://10.1136/bmjsrh-2019-200376 

[4] “Tenaculum: For over 100 years women have endured pain in gynecology”. (2020, Oct 28,). Aspivix. Retrieved Jan 2, 2024, from https://www.aspivix.com/tenaculum-for-over-100- years-women-have-endured-pain-in-gynecology/#:~:text=Inspired%20by%20the%20shape%20o f,changed%20and%20persists%20till%20today 

[5] “Usability, safety and efficacy of AspivixTM”. (2020, Dec 11,). ClinicalTrials.gov. Retrieved Jan 2, 2024, from https://clinicaltrials.gov/study/NCT04441333?term=Aspivix&check Spell=false&rank=1