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A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)
Sponsor: CooperSurgical Inc.
Summary
The purpose of this study is to demonstrate that a new device inserter leads to successful and safe insertion of Paragard® IUS, comparable to the currently approved IUS inserter, in females of reproductive potential.
Official title: A Post-Marketing, Prospective, Multi-Center, Single Arm, Open Label Clinical Study to Evaluate the Safety of a New Inserter Design for Paragard® T380A Intrauterine Copper Contraceptive
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
119
Start Date
2022-03-04
Completion Date
2022-12-08
Last Updated
2026-08-25
Healthy Volunteers
Yes
Conditions
Interventions
Paragard® T380A Intrauterine Copper Contraceptive with New Inserter
Paragard® IUS with Investigational Inserter combines the current insertion tube and white rod to form a new pre-assembled inserter device that supports a single hand operation. The device is used to pass the IUS through the cervical canal and into the uterine cavity and facilitates insertion of the T shaped Paragard® IUS implant into the uterus.
Locations (8)
Downtown Women's Healthcare
Denver, Colorado, United States
South Miami Women's Health
South Miami, Florida, United States
GYN-CARE Women's Healthcare
Atlanta, Georgia, United States
Valley Ob-Gyn Clinic, PC
Saginaw, Michigan, United States
Hilltop Obstetrics & Gynecology
Franklin, Ohio, United States
Central Austin - Women Partners in Health
Austin, Texas, United States
Austin Area Ob-Gyn & Fertility
Austin, Texas, United States
Seattle Clinical Research Center
Seattle, Washington, United States