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Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter
Rebecca F Dunsmoor-Su1, Vrunda B Desai1, Erica C Pandolfi1
1Seattle Clinical Research Center, Seattle, Washington; CooperSurgical, Inc., Trumbull, Connecticut; South Miami Hospital, Miami, Florida; Emory University, Atlanta, Georgia; Hilltop OB GYN, Cincinnati, Ohio; and McKain Consulting LLC, San Antonio, Texas.
Abstract:
In this clinical trial, a preassembled, single-hand Paragard T380A intrauterine copper contraceptive device inserter was investigated for insertion success and safety. The single-hand inserter was evaluated in a phase 4 multicenter study of 117 participants (NCT05309694). Successful insertion of the intrauterine system (IUS) was achieved on first attempt for 90.6% of participants (106/117) and on second attempt for 100% of participants (10/10), for an overall success rate of 99.1% (116/117). Investigators found the inserter easy to use and perceived a reduced time of insertion. No safety signals related to insertion were observed. After successful insertion, two participants experienced serious adverse events associated with major protocol deviations: uterine perforation and embedded IUS. Overall, the single-hand inserter for the T380A intrauterine copper contraceptive device demonstrated successful insertion.
Clinical Trial Registration:
ClinicalTrials.gov, NCT05309694.
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