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

January 18, 2024 updated by: Carrie Bell, MD, University of Michigan

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clip device removal
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.
Active Comparator: Standard of Care removal
Procedure: Standard of Care procedure
The participants Nexplanon will be removed per standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
During the intervention/procedure/surgery
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.
During the intervention/procedure/surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive
Time Frame: 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.
During the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

VentureWell

Investigators

  • Principal Investigator: Carrie Bell, MD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Actual)

June 16, 2021

Study Completion (Actual)

June 23, 2021

Study Registration Dates

First Submitted

May 27, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2024

Last Update Submitted That Met QC Criteria

January 18, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00172715

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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