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OpenTrials
Completed

NCT Number: NCT02986204

Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant

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.

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Key information

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

removal of ENG implant

Procedure

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

continuation of ING implant

Procedure

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

Primary outcomes

  1. Creation of image gallery

    Time frame: 18 months

    Creating an image gallery in order to locate ENG implant using ultrasound and radiological images

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Acronym: ENG

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Dec 8, 2016
Registry last updated
Apr 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.