Head of Gynecological Outpatient Unit - Pediatric and Adolescent Gynecology Geneva University Hospitals Geneva, Geneve, Switzerland
Introduction: Annual incidence of 121 million unintended pregnancies, remains a global health challenge. IUD constitutes one of the most efficient and safe contraceptive methods, but pain remains a key barrier. Methods: Real-world data were collected from 297 transcervical procedures using quantitative data, user and patient surveys, with qualitative feedback from healthcare professionals’ interviews (HCPs) and patients’ (88% IUD and 12% for diverse procedures at 11 hospitals/clinics across the US, Europe, and Switzerland between September 2023 and February 2024).
The data evaluates efficacy, patient reported experience, the device's versatility in diverse procedures, and user satisfaction measured through ease of use, adequate visibility, pulling strength of the suction cervical stabilizer Carevix™, and the reduction of discomfort for the patient. Results: The data show an overall success rate of 81%, and 91% excluding IUD.
The study demonstrated 88% patient satisfaction rate over 265 patients, as well as 82% over 170 patients reported manageable pain and “easy” procedure. 100% of US patients felt reassured when presented with a pain reduction device.
HCPs reported a rapid learning curve with Carevix with a success rate starting at 76% and increasing to 89% for over 10 times-users (n=83 uses).
Users reported 89% satisfaction regarding ease of use, 72% sufficient pulling strength, find visibility satisfactory at 78%, while 81% agree that patient discomfort is reduced with Carevix. Conclusion/Implications: The ongoing real-world study demonstrates that Carevix™ mitigates critical barriers to transcervical gynecological interventions by reducing pain and bleeding. We expect this new approach should become the new standard of care for transcervical interventions.