<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02986204</url>
  </required_header>
  <id_info>
    <org_study_id>version 1.0 07/25/16</org_study_id>
    <nct_id>NCT02986204</nct_id>
  </id_info>
  <brief_title>Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant</brief_title>
  <acronym>ENG</acronym>
  <official_title>Identification and Removal of the Non Palpable Etonogestrel Contraceptive Implant</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate in-office ultrasound localization vs localization in radiology&#xD;
      for identification and removal of non palpable etonogestrel (ENG) contraceptive implants and&#xD;
      aims to help establish best practices in this domain. Investigators will also create an&#xD;
      ultrasound image gallery of palpable and non palpable as well as instructional video for non&#xD;
      palpable ENG implant removal.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a descriptive study to establish best practices for ENG implant localization and&#xD;
      non-palpable ENG implant removal.&#xD;
&#xD;
      Women presenting to UCLA Obstetrics and Gynecology service for ENG non-palpable and palpable&#xD;
      implant removal or with ENG implant in place but desiring continuation will be enrolled.&#xD;
      Investigators aim to enroll 20 women in each group. Screening data will be reviewed to&#xD;
      determine subject eligibility. Subjects who meet all inclusion criteria will be entered into&#xD;
      the study.&#xD;
&#xD;
      Study duration for each participant is one visit for continuation group and two weeks for&#xD;
      group desiring implant removal. Total study duration is expected to be 18 months.&#xD;
&#xD;
        1. For women desiring implant removal: document ENG implant using in-office imaging of ENG&#xD;
           implant in the FP clinic with standard ob/gyn office ultrasound (abdominal 15 MHz linear&#xD;
           probe with color doppler) and the same, using high frequency vascular probe (20+ MHz) in&#xD;
           the radiology department.&#xD;
&#xD;
        2. Create an image gallery of office and radiology department obtained images of ENG&#xD;
           implant localization. This will include:&#xD;
&#xD;
             1. Ultrasound images obtained in women with palpable or non-palpable ENG implants in&#xD;
                place at various time intervals after insertion who desire ENG implant continuation&#xD;
                (office imaging only).&#xD;
&#xD;
             2. Ultrasound images obtained in women seeking removal of non-palpable ENG implants,&#xD;
                primarily referred patients who have either failed outside implant removal or have&#xD;
                a non-palpable implant on presentation for removal.&#xD;
&#xD;
        3. Document and describe all cases of non palpable ENG implant removal with standard,&#xD;
           in-office US versus radiology ultrasound equipment. Investigators will collect&#xD;
           radiographic images, clinical findings, instruments used, patient characteristics (BMI,&#xD;
           weight gain, time since of insertion), success of procedure, duration of procedure,&#xD;
           number of attempts, final location of implant, and need for referral to general or&#xD;
           vascular surgeon.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">May 2020</completion_date>
  <primary_completion_date type="Actual">May 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Creation of image gallery</measure>
    <time_frame>18 months</time_frame>
    <description>Creating an image gallery in order to locate ENG implant using ultrasound and radiological images</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Creation of an instructional video and reference guide for ENG implant removal.</measure>
    <time_frame>18 months</time_frame>
    <description>If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Women With an ENG Contraceptive Implant</condition>
  <arm_group>
    <arm_group_label>removal of ENG implant group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>continuation of ENG implant</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>20 women who have are continuing to use their ENG implant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>removal of ENG implant</intervention_name>
    <description>the researcher(s) will ask you to: Visit 1 - SCREENING VISIT&#xD;
questions about your medical/contraception history&#xD;
Review medical record&#xD;
physical examination&#xD;
urine sample for pregnancy test&#xD;
Visit 2a - Radiology&#xD;
Have an ultrasound of your arm&#xD;
The radiologist will mark your arm at the location of the implant.&#xD;
Visit 2b&#xD;
ultrasound of your arm to locate the implant. This is done by feeling the area.&#xD;
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.&#xD;
Have the removal procedure video recorded.&#xD;
Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:&#xD;
Provide a urine sample for pregnancy test&#xD;
Have the implant removal site examined</description>
    <arm_group_label>removal of ENG implant group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>continuation of ING implant</intervention_name>
    <description>the researcher(s) will ask you to:&#xD;
To answer questions about your medical and contraception history&#xD;
Review your medical record&#xD;
Have a physical examination by the researcher&#xD;
Provide a urine sample for pregnancy test&#xD;
Have an ultrasound of your arm</description>
    <arm_group_label>continuation of ENG implant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women age 18 - 50 years old&#xD;
&#xD;
          -  English or Spanish speaking&#xD;
&#xD;
          -  ENG implant in place&#xD;
&#xD;
          -  Removal group&#xD;
&#xD;
             o Women with non palpable ENG implant desiring ENG implant removal&#xD;
&#xD;
          -  Continuation group o Women with palpable or non-palpable ENG implant desiring&#xD;
             continuation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known or suspected pregnancy&#xD;
&#xD;
          -  Does not meet inclusion criteria&#xD;
&#xD;
          -  Known ENG implant location outside of arm&#xD;
&#xD;
          -  Current anticoagulation use (removal group only)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>UCLA Dept. OB/GYN Div. of Family Planning</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, Los Angeles</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UCLA Dept. OB/GYN, Women's Health CRU, 10833 Le Conte Ave, CHS 22-265</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <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>
    <PMID>22939402</PMID>
  </reference>
  <reference>
    <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>
    <PMID>24081828</PMID>
  </reference>
  <reference>
    <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>
    <PMID>25081861</PMID>
  </reference>
  <reference>
    <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>
    <PMID>26444124</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>16857066</PMID>
  </reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 8, 2016</study_first_posted>
  <last_update_submitted>April 28, 2021</last_update_submitted>
  <last_update_submitted_qc>April 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Angela Chen, MD</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <keyword>implant removal</keyword>
  <keyword>Nexplanon</keyword>
  <keyword>Implanon</keyword>
  <keyword>contraception</keyword>
  <keyword>ENG</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02986204
org study id: version 1.0 07/25/16
nct id: NCT02986204
lead sponsor: 
has dmc: No
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.
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Creation of image gallery
time frame: 18 months
description: Creating an image gallery in order to locate ENG implant using ultrasound and radiological images
measure: Creation of an instructional video and reference guide for ENG implant removal.
time frame: 18 months
description: If ultrasound/radiological images are successful at locating ENG implant, this data could lead to the creation of a reference guide for other providers.
arm group label: removal of ENG implant group
arm group type: Other
description: 20 women who have an ENG implant that is difficult to feel on exam and would like to have it removed.
arm group label: continuation of ENG implant
arm group type: Other
description: 20 women who have are continuing to use their ENG implant.
intervention type: Procedure
intervention name: removal of ENG implant
description: 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
arm group label: removal of ENG implant group
intervention type: Procedure
intervention name: continuation of ING implant
description: 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
arm group label: continuation of ENG implant
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: UCLA Dept. OB/GYN Div. of Family Planning
role: Principal Investigator
affiliation: University of California, Los Angeles
facility: 
country: United States
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.
PMID: 22939402
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.
PMID: 24081828
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.
PMID: 25081861
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.
PMID: 26444124
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.
PMID: 16857066
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Angela Chen, MD
investigator title: Principle Investigator
sharing ipd: No