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

Not Applicable

Terminated

• Conditions: Contraception
• Interventions: Procedure: Standard of Care procedure; Device: Clip device for Nexplanon Removal

• Registration Number: NCT04919395
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-05-27
• Study First Submitted QC: 2021-06-08
• Study First Posted: 2021-06-09
• Study Start: 2021-06-16
• Primary Completion: 2021-06-16
• Study Completion: 2021-06-23
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

• Currently using Nexplanon and requesting removal
• Qualifies for outpatient removal
• Ability to understand and sign informed consent

Read More

Exclusion Criteria

• Pregnancy
• Any rashes or skin conditions around the insertion site
• Known allergy to lidocaine
• Known allergy to biocompatible plastics or stainless steel

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard of Care removal	Standard of Care procedure	-
Clip device removal	Clip device for Nexplanon Removal	-

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States