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

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Women With an ENG Contraceptive Implant

Treatments: Procedure: continuation of ING implant; Procedure: removal of ENG implant

Study type: Interventional

Funder types: Other

Identifiers

NCT02986204

version 1.0 07/25/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

removal of ENG implant group

Other group

Description:

20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.

Treatment:

Procedure: removal of ENG implant

continuation of ENG implant

Other group

Description:

20 women who have are continuing to use their ENG implant.

Treatment:

Procedure: continuation of ING implant