Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant

Not Applicable

Completed

• Conditions: Women With an ENG Contraceptive Implant
• Interventions: Procedure: continuation of ING implant; Procedure: removal of ENG implant

• Registration Number: NCT02986204
• Lead Sponsor: University of California, Los Angeles

Brief Summary

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

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 Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-05
• Study First Posted: 2016-12-08
• Study Start: 2017-01
• Primary Completion: 2020-05
• Study Completion: 2020-05
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
continuation of ENG implant	continuation of ING implant	20 women who have are continuing to use their ENG implant.
removal of ENG implant group	removal of ENG implant	20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.

Primary Outcome Measures

Name	Time	Method
Creation of image gallery	18 months	Creating an image gallery in order to locate ENG implant using ultrasound and radiological images

Secondary Outcome Measures

Name	Time	Method
Creation of an instructional video and reference guide for ENG implant removal.	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.

Trial Locations

Locations (1)

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