Evaluation of a "Clip" Device Added to the Current Standard Removal of Contraceptive Implant to Improve Stability of the Implant, Shorten Removal Time, and Increase the Ease of Removal
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Contraception
- Sponsor
- University of Michigan
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Length of incision used for the removal of the single rod contraceptive implant device
- Status
- Terminated
- Last Updated
- 2 years ago
Overview
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.
Investigators
Carrie Bell, MD
Associate Professor of Obstetrics and Gynecology
University of Michigan
Eligibility Criteria
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
Outcomes
Primary Outcomes
Length of incision used for the removal of the single rod contraceptive implant device
Time Frame: During the intervention/procedure/surgery
This will be recorded for both groups.
Time to remove the contraceptive implant device
Time Frame: During the intervention/procedure/surgery
The amount of time that it takes to remove the contraceptive implant will be noted for both groups.
Secondary Outcomes
- Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive(During the intervention/procedure/surgery)