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On the single day that the study was open, it became clear that modifications to the clip would be required. Only late in 2023 did it become clear that any continuation of the project would require a new trial.
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| Name | Class |
|---|---|
| VentureWell | INDUSTRY |
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This trial is being completed to understand how the study "Clip" device works when assisting clinicians with Nexplanon removals. The study device clips to the skin to hold the implant still and raise the tip of the implant during removal. The study device may improve the process for removing under arm implants by decreasing procedure time and improving the ease and safety of the procedure.
The results from this study will help the researchers understand whether the study device has the potential to simplify the removal procedure and make this form of birth control safer for patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clip device removal | Experimental |
| |
| Standard of Care removal | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clip device for Nexplanon Removal | Device | The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to remove the contraceptive implant device | The amount of time that it takes to remove the contraceptive implant will be noted for both groups. | During the intervention/procedure/surgery |
| Length of incision used for the removal of the single rod contraceptive implant device | This will be recorded for both groups. | During the intervention/procedure/surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive | Participants will be asked to rate the pain they experienced during the procedure. Subjects will choose the face that best illustrates the pain they experienced during the procedure. Each face corresponds to a value on a 0-10 scale, with a higher score corresponding to more pain. | During the intervention/procedure/surgery |
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Inclusion Criteria:
Exclusion Criteria:
This is a study for participants using birth control.
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| Name | Affiliation | Role |
|---|---|---|
| Carrie Bell, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D013525 | Surgical Instruments |
| ID | Term |
|---|---|
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.
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| Standard of Care procedure | Procedure | The participants Nexplanon will be removed per standard of care. |
|