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

NCT05309694 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 119

Last updated 2023-01-20

No results posted yet for this study

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.

Conditions

  • Contraception

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.

Sponsors & Collaborators

  • CooperSurgical Inc.

    lead INDUSTRY

Principal Investigators

  • Robin Kroll, MD · Seattle Clinical Research Center

  • Carol Stamm, MD · Downtown Women's Healthcare

  • Joyce Miller, MD · South Miami Women's Health

  • Jacquelyn Robinson, MD · Valley Ob-Gyn Clinic, PC

  • Ronald Hirth, MD · Hilltop Obstetrics & Gynecology

  • Mark Akin, MD · Austin Area Ob-Gyn & Fertility

  • Stephanie Reich, MD · Central Austin - Women Partners in Health

  • Eric L Brown, MD · GYN-CARE Women's Healthcare

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-04
Primary Completion
2022-12-08
Completion
2022-12-08
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05309694 on ClinicalTrials.gov