Assessing Pain and Effectiveness of Carevix Device for IUD Insertions

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2025
The primary objective is to assess and compare patient‐reported pain during IUD insertionbetween the Carevix device and tenaculum. The hypothesis is that patient‐reported painscores comparing Carevix™ to tenaculum will be lower. The investigators will assess pain,and predictors for pain scores including nulliparous vs multiparous, when highest painscores are reported, and expectation of pain for the procedure.The secondary objective will be to assess Usability (provider assessment of ease of use,number of device placement attempts to secure sufficient traction on uterus), efficacy(ability to insert IUD with Carevix™ device alone without recourse to conventionaltenaculum or other instruments), provider reported bleeding (cervical bleeding andecchymosis), overall provider satisfaction, patient‐reported pain scores at deviceplacement prior to IUD insertion procedure and after completion of IUD insertion usingVisual Analog Scale (VAS), overall patient satisfaction, and overall providersatisfaction. The investigators aim to expand the pilot trial data collection to assesscultural background, ethnicity and demographics while also assessing prior contraceptivechoices, reasons for discontinuation of prior choices and reasons for current selectionof IUD insertion and any anticipated barriers for removal.
Epistemonikos ID: a0777cbe7083baa4077bb2d9b756fecf5d14b4b4
First added on: Dec 19, 2025