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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04919395
• Other study ID #: HUM00172715
• Status: Terminated
• Phase: N/A
• Start date: June 16, 2021
• Est. completion date: June 23, 2021

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: June 23, 2021
• Est. primary completion date: June 16, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Contraception

Intervention

Device:
• Clip device for Nexplanon Removal
The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject.

Procedure:
• Standard of Care procedure
The participants Nexplanon will be removed per standard of care.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	VentureWell

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Secondary	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