Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant

Study Overview
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Brief Summary
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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.

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

Official Title
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Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant

Conditions
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Women With an ENG Contraceptive Implant

Intervention / Treatment
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* Procedure: removal of ENG implant
* Procedure: continuation of ING implant


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: removal of ENG implant group<br>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<br>* 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<br>|
| Other: continuation of ENG implant<br>20 women who have are continuing to use their ENG implant. | Procedure: continuation of ING implant<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creation of image gallery | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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implant removal, Nexplanon, Implanon, contraception, ENG