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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.
This is a post-market prospective clinical study to be conducted at multiple centers in a single arm and open-label design to evaluate the safety of a new inserter design for Paragard® (intrauterine copper contraceptive). The study will be conducted in female subjects of child bearing potential.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Other | Paragard® T380A Intrauterine Copper Contraceptive with new inserter Non parous and parous female subjects of child bearing potential |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paragard® T380A Intrauterine Copper Contraceptive with New Inserter | Combination Product | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Insertions | The percentage of successful insertions will be calculated by number of subjects with successful insertions relative to the total number of subjects with at least one successful or unsuccessful insertion attempt. | From enrollment to end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Uterine Perforation and IUD Embedment | Frequency of uterine perforation and IUD embedment | From enrollment to end of treatment at 3 months |
| IUS Expulsions and Dislocations | Frequency of IUS expulsions (partial or total) and dislocations |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robin Kroll, MD | Seattle Clinical Research Center | Principal Investigator |
| Carol Stamm, MD | Downtown Women's Healthcare | Principal Investigator |
| Joyce Miller, MD | South Miami Women's Health | Principal Investigator |
| Jacquelyn Robinson, MD | Valley Ob-Gyn Clinic, PC | Principal Investigator |
| Ronald Hirth, MD | Hilltop Obstetrics & Gynecology | Principal Investigator |
| Mark Akin, MD | Austin Area Ob-Gyn & Fertility | Principal Investigator |
| Stephanie Reich, MD | Central Austin - Women Partners in Health | Principal Investigator |
| Eric L Brown, MD | GYN-CARE Women's Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Downtown Women's Healthcare | Denver | Colorado | 80218 | United States | ||
| South Miami Women's Health |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41000288 | Derived | Dunsmoor-Su RF, Desai VB, Pandolfi EC, Audette CR, Miller JR, Fuller AE, Brown EL, Hirth RD, Seetal-Kihei KV, McKain LF. Placement of the T380A Intrauterine Copper Contraceptive Using a Single-Hand Inserter. O G Open. 2025 Mar 6;2(2):e068. doi: 10.1097/og9.0000000000000068. eCollection 2025 Apr. |
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Single arm and open-label design
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|
| From enrollment to end of treatment at 3 months |
| Adverse Events | Frequency of Serious Adverse Events (SAE) and Adverse Events (AE) | From enrollment to end of treatment at 3 months |
| Adverse Events related to Procedure | Frequency of AEs related to procedure | From enrollment to end of treatment at 3 months |
| Vasovagal Events | Frequency of vasovagal events at the time of insertion | From enrollment to end of treatment at 3 months |
| Pelvic Infections | Frequency of pelvic infections related to IUS insertion and use | From enrollment to end of treatment at 3 months |
| South Miami |
| Florida |
| 33143 |
| United States |
| GYN-CARE Women's Healthcare | Atlanta | Georgia | 30363 | United States |
| Valley Ob-Gyn Clinic, PC | Saginaw | Michigan | 48602 | United States |
| Hilltop Obstetrics & Gynecology | Franklin | Ohio | 45005 | United States |
| Central Austin - Women Partners in Health | Austin | Texas | 78705 | United States |
| Austin Area Ob-Gyn & Fertility | Austin | Texas | 78758 | United States |
| Seattle Clinical Research Center | Seattle | Washington | 98105 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 6, 2026 |