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

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ClinicalTrials.gov Identifier: NCT02986204
Recruitment Status : Not yet recruiting
First Posted : December 8, 2016
Last Update Posted : December 12, 2016
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Women With an ENG Contraceptive Implant Procedure: removal of ENG implant Procedure: continuation of ING implant Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
Study Start Date : January 2017
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02986204


Contacts
Contact: UCLA Dept. OB/GYN Women's Health CRU 310 825 0580 UCLAOBGYNResearch@mednet.ucla.edu

Locations
United States, California
UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265 Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Ross M. Divinagracia    310-825-0580    UCLAOBGYNResearch@mednet.ucla.edu   
Contact: Sonali S Namiranian    310-794-9095      
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: UCLA Dept. OB/GYN Div. of Family Planning University of California, Los Angeles

Publications:
Responsible Party: University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02986204     History of Changes
Other Study ID Numbers: version 1.0 07/25/16
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 12, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of California, Los Angeles:
implant removal
Nexplanon
Implanon
contraception
ENG

Additional relevant MeSH terms:
Contraceptive Agents
Etonogestrel
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female