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

NCT ID: NCT04919395

Last Updated: 2024-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-16

Study Completion Date

2021-06-23

Brief Summary

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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

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Conditions

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Contraception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Information regarding the planned intervention study model was removed, as the trial did not meet its recruitment goals.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Clip device removal

Group Type EXPERIMENTAL

Clip device for Nexplanon Removal

Intervention Type DEVICE

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

Standard of Care removal

Group Type ACTIVE_COMPARATOR

Standard of Care procedure

Intervention Type PROCEDURE

The participants Nexplanon will be removed per standard of care.

Interventions

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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.

Intervention Type DEVICE

Standard of Care procedure

The participants Nexplanon will be removed per standard of care.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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VentureWell

INDUSTRY

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role lead

Responsible Party

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Carrie Bell, MD

Associate Professor of Obstetrics and Gynecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Carrie Bell, MD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

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University of Michigan

Ann Arbor, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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HUM00172715

Identifier Type: -

Identifier Source: org_study_id

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