Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
NCT ID: NCT02986204
Last Updated: 2021-04-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2017-01-31
2020-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
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
Interventions
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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 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
Eligibility Criteria
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Inclusion Criteria
* 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
* Known ENG implant location outside of arm
* Current anticoagulation use (removal group only)
Exclusion Criteria
18 Years
50 Years
FEMALE
Yes
Sponsors
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University of California, Los Angeles
OTHER
Responsible Party
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Angela Chen, MD
Principle Investigator
Principal Investigators
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UCLA Dept. OB/GYN Div. of Family Planning
Role: PRINCIPAL_INVESTIGATOR
University of California, Los Angeles
Locations
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UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265
Los Angeles, California, United States
Countries
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References
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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.
Pillai 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.
Guiahi 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.
Chen 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.
Singh 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.
Other Identifiers
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version 1.0 07/25/16
Identifier Type: -
Identifier Source: org_study_id
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