Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter
Year: 2025
Type: article
Study design: Clinical Trial
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.
Source: O&G Open
Institutions: Emory University, CooperSurgical (United States)
Language: English
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4408178705