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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.

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|September 26, 2025
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Summary

A new single-hand inserter for the Paragard T380A intrauterine copper contraceptive device showed a 99.1% success rate in clinical trials. This device is easy to use and safe for intrauterine system insertion.

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Area of Science:

  • Contraception and Family Planning
  • Medical Device Technology
  • Clinical Gynecology

Background:

  • ClinicalTrials.gov identifier: NCT05309694.
  • Evaluation of a novel preassembled, single-hand inserter for the Paragard T380A intrauterine copper contraceptive device.

Purpose of the Study:

  • To assess the insertion success and safety of a single-hand inserter for the Paragard T380A intrauterine copper contraceptive device.
  • To evaluate the ease of use and insertion time associated with the novel inserter.

Main Methods:

  • Phase 4 multicenter study involving 117 participants.
  • Investigated insertion success rates on first and second attempts.
  • Monitored for safety signals related to the insertion procedure.

Main Results:

  • Overall insertion success rate of 99.1% (116/117 participants).
  • 90.6% (106/117) successful first-attempt insertions.
  • Investigators reported ease of use and perceived reduced insertion time.
  • No safety signals directly related to insertion were observed.

Conclusions:

  • The single-hand inserter for the Paragard T380A intrauterine copper contraceptive device is effective and safe for IUS insertion.
  • The device offers a high success rate and ease of use for healthcare providers.
  • Further monitoring for rare adverse events like uterine perforation is important.