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COMPLETED
NCT05309694
PHASE4

A Study to Assess the Safety of a New Inserter Device for Paragard® (Intrauterine Copper Contraceptive)

Sponsor: CooperSurgical Inc.

View on ClinicalTrials.gov

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

COMBINATION_PRODUCT

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