Contraception
Conditions
Keywords
Nexplanon removal, Medical device
Brief summary
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.
Interventions
DEVICEClip device for Nexplanon Removal
The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject.
PROCEDUREStandard of Care procedure
The participants Nexplanon will be removed per standard of care.
Sponsors
VentureWell
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
Inclusion criteria
* Currently using Nexplanon and requesting removal * Qualifies for outpatient removal * Ability to understand and sign informed consent
Exclusion criteria
* Pregnancy * Any rashes or skin conditions around the insertion site * Known allergy to lidocaine * Known allergy to biocompatible plastics or stainless steel
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to remove the contraceptive implant device | During the intervention/procedure/surgery | The amount of time that it takes to remove the contraceptive implant will be noted for both groups. |
| Length of incision used for the removal of the single rod contraceptive implant device | During the intervention/procedure/surgery | This will be recorded for both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive | During the intervention/procedure/surgery | 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. |
Countries
United States
Outcome results
None listed