Clinical trial NCT02986204: Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
Official title: Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Women With an ENG Contraceptive Implant
Keywords: implant removal
Nexplanon
Implanon
contraception
ENG
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2016-12-08
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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)

Primary outcomes:
measure: Creation of image gallery
timeFrame: 18 months
Secondary outcomes:
measure: Creation of an instructional video and reference guide for ENG implant removal.
timeFrame: 18 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265
state: California
Study officials:
affiliation: University of California, Los Angeles
name: UCLA Dept. OB/GYN Div. of Family Planning
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.