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

NCT04919395 | Terminated

• 1 other identifier: HUM00172715
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Contraception

Keywords

Nexplanon removal; Medical device

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Pain based on the Wong-Baker FACES Pain rating scale from the removal of single rod contraceptive

  During the intervention/procedure/surgery

Study Arms (2)

Clip device removal

EXPERIMENTAL

Device: Clip device for Nexplanon Removal

Standard of Care removal

ACTIVE COMPARATOR

Procedure: Standard of Care procedure

Interventions

Clip device for Nexplanon Removal DEVICE

The clip device will be used to assist in the removal procedure to remove the Nexplanon implant from the subject.

Clip device removal

Standard of Care procedure PROCEDURE

The participants Nexplanon will be removed per standard of care.

Standard of Care removal

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: This is a study for participants using birth control.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• VentureWell: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Interventions

Surgical Instruments

Intervention Hierarchy (Ancestors)

Surgical Equipment; Equipment and Supplies

Study Officials

• Carrie Bell, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Obstetrics and Gynecology

Model Details: Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.

Study Record Dates

• First Submitted: May 27, 2021
• First Posted: June 9, 2021
• Study Start: June 16, 2021
• Primary Completion: June 16, 2021
• Study Completion: June 23, 2021
• Last Updated: January 22, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)