Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant (ENG)

April 28, 2021 updated by: Angela Chen, MD, University of California, Los Angeles
This study will investigate in-office ultrasound localization vs localization in radiology for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and aims to help establish best practices in this domain. Investigators will also create an ultrasound image gallery of palpable and non palpable as well as instructional video for non palpable ENG implant removal.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a descriptive study to establish best practices for ENG implant localization and non-palpable ENG implant removal.

Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable implant removal or with ENG implant in place but desiring continuation will be enrolled. Investigators aim to enroll 20 women in each group. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria will be entered into the study.

Study duration for each participant is one visit for continuation group and two weeks for group desiring implant removal. Total study duration is expected to be 18 months.

  1. For women desiring implant removal: document ENG implant using in-office imaging of ENG implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in the radiology department.

  2. Create an image gallery of office and radiology department obtained images of ENG implant localization. This will include:

    1. Ultrasound images obtained in women with palpable or non-palpable ENG implants in place at various time intervals after insertion who desire ENG implant continuation (office imaging only).
    2. Ultrasound images obtained in women seeking removal of non-palpable ENG implants, primarily referred patients who have either failed outside implant removal or have a non-palpable implant on presentation for removal.
  3. Document and describe all cases of non palpable ENG implant removal with standard, in-office US versus radiology ultrasound equipment. Investigators will collect radiographic images, clinical findings, instruments used, patient characteristics (BMI, weight gain, time since of insertion), success of procedure, duration of procedure, number of attempts, final location of implant, and need for referral to general or vascular surgeon.

Study Type

Interventional

Enrollment (Actual)

40

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
    • California
      • Los Angeles, California, United States, 90095
        • UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women age 18 - 50 years old
  • English or Spanish speaking
  • ENG implant in place

  • Removal group

    o Women with non palpable ENG implant desiring ENG implant removal

  • Continuation group o Women with palpable or non-palpable ENG implant desiring continuation

Exclusion Criteria:

  • Known or suspected pregnancy
  • Does not meet inclusion criteria
  • Known ENG implant location outside of arm
  • Current anticoagulation use (removal group only)

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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: removal of ENG implant group
20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.
Procedure: removal of ENG implant

the researcher(s) will ask you to: Visit 1 - SCREENING VISIT

  • questions about your medical/contraception history
  • Review medical record
  • physical examination
  • urine sample for pregnancy test

Visit 2a - Radiology

  • Have an ultrasound of your arm
  • The radiologist will mark your arm at the location of the implant.

Visit 2b

  • ultrasound of your arm to locate the implant. This is done by feeling the area.
  • Have your ENG implant removed through a numbed small cut. The researcher will apply a pressure bandage to the site(s). This will reduce bleeding/decrease swelling.
  • Have the removal procedure video recorded.

Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:

  • Provide a urine sample for pregnancy test
  • Have the implant removal site examined
Other: continuation of ENG implant
20 women who have are continuing to use their ENG implant.
Procedure: continuation of ING implant

the researcher(s) will ask you to:

  • To answer questions about your medical and contraception history
  • Review your medical record
  • Have a physical examination by the researcher
  • Provide a urine sample for pregnancy test
  • Have an ultrasound of your arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of image gallery
Time Frame: 18 months
Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Creation of an instructional video and reference guide for ENG implant removal.
Time Frame: 18 months
If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers.
18 months

Collaborators and Investigators

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

Sponsor

University of California, Los Angeles

Investigators

  • Principal Investigator: UCLA Dept. OB/GYN Div. of Family Planning, University of California, Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 1, 2020

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 5, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

April 30, 2021

Last Update Submitted That Met QC Criteria

April 28, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • version 1.0 07/25/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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