Preliminary Evaluation of a "Clip" Device for Contraceptive Implant Removal

University of Michigan

Status: Terminated

Conditions: Contraception

Treatments: Device: Clip device for Nexplanon Removal; Procedure: Standard of Care procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04919395

HUM00172715

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

4 participants in 2 patient groups

Clip device removal

Experimental group

Treatment:

Device: Clip device for Nexplanon Removal

Standard of Care removal

Active Comparator group

Treatment:

Procedure: Standard of Care procedure