Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
ENG
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 2, 2016
CompletedFirst Posted
Study publicly available on registry
December 8, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2020
CompletedApril 30, 2021
April 1, 2021
3.3 years
December 2, 2016
April 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Creation of image gallery
Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
18 months
Secondary Outcomes (1)
Creation of an instructional video and reference guide for ENG implant removal.
18 months
Study Arms (2)
removal of ENG implant group
OTHER20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.
continuation of ENG implant
OTHER20 women who have are continuing to use their ENG implant.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Known or suspected pregnancy
- Known ENG implant location outside of arm
- Current anticoagulation use (removal group only)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265
Los Angeles, California, 90095, United States
Related Publications (5)
Mommers E, Blum GF, Gent TG, Peters KP, Sordal TS, Marintcheva-Petrova M. Nexplanon, a radiopaque etonogestrel implant in combination with a next-generation applicator: 3-year results of a noncomparative multicenter trial. Am J Obstet Gynecol. 2012 Nov;207(5):388.e1-6. doi: 10.1016/j.ajog.2012.08.002. Epub 2012 Aug 10.
PMID: 22939402BACKGROUNDPillai M, Gazet AC, Griffiths M. Continuing need for and provision of a service for non-standard implant removal. J Fam Plann Reprod Health Care. 2014 Apr;40(2):126-32. doi: 10.1136/jfprhc-2013-100619. Epub 2013 Sep 30.
PMID: 24081828BACKGROUNDGuiahi M, Tocce K, Teal S, Green T, Rochon P. Removal of a Nexplanon implant located in the biceps muscle using a combination of ultrasound and fluoroscopy guidance. Contraception. 2014 Dec;90(6):606-8. doi: 10.1016/j.contraception.2014.06.030. Epub 2014 Jun 27.
PMID: 25081861BACKGROUNDChen MJ, Creinin MD. Removal of a Nonpalpable Etonogestrel Implant With Preprocedure Ultrasonography and Modified Vasectomy Clamp. Obstet Gynecol. 2015 Nov;126(5):935-938. doi: 10.1097/AOG.0000000000001082.
PMID: 26444124BACKGROUNDSingh M, Mansour D, Richardson D. Location and removal of non-palpable Implanon implants with the aid of ultrasound guidance. J Fam Plann Reprod Health Care. 2006 Jul;32(3):153-6. doi: 10.1783/147118906777888549.
PMID: 16857066BACKGROUND
Study Officials
- PRINCIPAL INVESTIGATOR
UCLA Dept. OB/GYN Div. of Family Planning
University of California, Los Angeles
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
December 2, 2016
First Posted
December 8, 2016
Study Start
January 1, 2017
Primary Completion
May 1, 2020
Study Completion
May 1, 2020
Last Updated
April 30, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share