<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/NCT02986971</url>
  </required_header>
  <id_info>
    <org_study_id>REVALID</org_study_id>
    <nct_id>NCT02986971</nct_id>
  </id_info>
  <brief_title>Removal of Palpable Subdermal Contraceptive Rod Implants.</brief_title>
  <official_title>A Prospective, Single-centre, Non-comparative Feasibility Investigation to Evaluate Performance and Safety of RemovAid ™ Retrieval Device When Used for Removal of Palpable Subdermal Contraceptive Rod Implants.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>RemovAid AS</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Karolinska University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bill and Melinda Gates Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>The Research Council of Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Amano Clinical Consulting AB</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>RemovAid AS</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      There are no implant removal devices on the market by any manufacturer. New features are&#xD;
      described in comparison with the existing removal technique. Overall, the RemovAid™ combines&#xD;
      the features of fixation, incision and extraction. This combination of functions has not&#xD;
      previously been combined in a single device.&#xD;
&#xD;
      The investigators wish to perform this pilot clinical investigation with the aim to&#xD;
      demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and&#xD;
      effectively facilitate implant removal. Other aims are to show that the IMD have the&#xD;
      potential to reduce procedure length variability, reduce procedural complexity and reduce the&#xD;
      need for additional procedural equipment related to CI removal procedures, without causing&#xD;
      any harm to the subject.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s.&#xD;
      They are advocated as a safe and effective method of contraception, and are included on the&#xD;
      WHO's Essential Medicines list.&#xD;
&#xD;
      CI manufacturers have focused intense efforts on making insertion of CIs easier, but have&#xD;
      largely left CI removals untouched and at the mercy of the various service providers.&#xD;
      Different introducers and trocars are available for use with the different CI systems&#xD;
      available internationally, and a second generation, single-use trocar is supplied with the&#xD;
      Nexplanon® implant system available in Sweden. This second generation trocar has reduced the&#xD;
      number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing&#xD;
      minor surgical procedures through the use of dedicated medical devices.&#xD;
&#xD;
      The CI removal procedure recommendations have remained essentially unchanged for 40 years,&#xD;
      relying on scalpels, forceps and general surgical skills from the service provider.&#xD;
      Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal&#xD;
      device is found on the commercial market.&#xD;
&#xD;
      Removal of palpable subdermal implants is generally a simple, minor surgical office&#xD;
      procedure. However, the procedure for implant removal requires more training and skill than&#xD;
      the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden&#xD;
      movement by the client causing inadvertent deeper penetration, in which case any underlying&#xD;
      structure could be affected.&#xD;
&#xD;
      Mean removal times, from time of incision until removal of the rod, are consistently reported&#xD;
      as less than four minutes, however with ranges from 0.2 - 60 minutes.&#xD;
&#xD;
      Available research shows that the procedure length of the current CI removal procedure is&#xD;
      highly variable and reliant on individual operator skills.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Minor design modifications to device to be investigated in new trial&#xD;
  </why_stopped>
  <start_date type="Actual">January 11, 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 19, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Successful removal of implant</measure>
    <time_frame>5 minutes</time_frame>
    <description>Percentage of fixated implants that were successfully removed without the use of additional tools.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Frequency, severity, causality and outcome of adverse events (AEs)</measure>
    <time_frame>1 week</time_frame>
    <description>Frequency and severity of sharps injury, nerve damage, blood vessel damage, tissue damage, wound infection and cytotoxicity during and after the use of the device. Performed by investigation of site at the time of operation and one week later.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain during procedure</measure>
    <time_frame>5 minutes</time_frame>
    <description>Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale (VAS) 0-100 mm ruler, assuming that anaesthesia has been properly administered.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success of fixation of implant</measure>
    <time_frame>5 minutes</time_frame>
    <description>Percentage of palpable implants where the implant could be seen and/or felt on both sides of the clamp after maximum three attempts of fixation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of procedure</measure>
    <time_frame>25 minutes</time_frame>
    <description>Mean time from&#xD;
making incision until implant is removed.&#xD;
first handling the device until closing the wound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical functionality of device determined by an operators questionnaire.</measure>
    <time_frame>5 minutes</time_frame>
    <description>Fulfilment of pre-defined technical requirements, as documented on an operator functionality questionnaire.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operators impression of the device</measure>
    <time_frame>5 minutes</time_frame>
    <description>The operator's global impression of the IMD will be assessed using a 5-point scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject satisfaction</measure>
    <time_frame>5 minutes</time_frame>
    <description>The subject's global assessment of satisfaction with the procedure will be assessed using a 5- point scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Removal of Contraceptive Implant</condition>
  <arm_group>
    <arm_group_label>New IMD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>New IMD</intervention_name>
    <description>The contraceptive implants of the subjects in this arm are removed by the new IMD.</description>
    <arm_group_label>New IMD</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female age 18 or older&#xD;
&#xD;
          -  Willing to remove a palpable subdermal Implanon/ Neplanon CI&#xD;
&#xD;
          -  Willing and able to give written informed consent for participation in the&#xD;
             investigation&#xD;
&#xD;
          -  Willing to provide follow-up information according to the Clinical Investigators&#xD;
             Brouchure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to local anaesthetic (lidocaine/lignocaine) or disinfectant&#xD;
             (chlorhexidine).&#xD;
&#xD;
          -  Active skin lesion over the CI.&#xD;
&#xD;
          -  The Investigator considers the subject unlikely to comply with investigational&#xD;
             procedures, restrictions and requirements.&#xD;
&#xD;
          -  Any contraindication for removal of the PI, as judged by the Investigator.&#xD;
&#xD;
          -  Any disorders or medications that might affect coagulation, as judged by the&#xD;
             Investigator.&#xD;
&#xD;
          -  Any conditions suspected to affect healing or increase risk of infection (e.g. keloid&#xD;
             tendency, diabetes or any upper arm dermatological condition that may affect upper arm&#xD;
             healing).&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marte Bratlie, MD</last_name>
    <role>Study Chair</role>
    <affiliation>RemovAid AS</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>17176</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <reference>
    <citation>Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.</citation>
    <PMID>22996129</PMID>
  </reference>
  <reference>
    <citation>World Health Organization. 2014 [cited April 23rd.]; Available from: http://www.who.int/medicines/publications/essentialmedicines/en/</citation>
  </reference>
  <reference>
    <citation>Mansour D, Mommers E, Teede H, Sollie-Eriksen B, Graesslin O, Ahrendt HJ, Gemzell-Danielsson K. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception. 2010 Sep;82(3):243-9. doi: 10.1016/j.contraception.2010.04.007. Epub 2010 May 18.</citation>
    <PMID>20705152</PMID>
  </reference>
  <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>Webb AM. Why go to Tiger Country? A report of two cases of Implanon removal. J Fam Plann Reprod Health Care. 2006 Jul;32(3):193-4. doi: 10.1783/147118906777888233. No abstract available.</citation>
    <PMID>16857083</PMID>
  </reference>
  <reference>
    <citation>Levine JP, Sinofsky FE, Christ MF; Implanon US Study Group. Assessment of Implanon insertion and removal. Contraception. 2008 Nov;78(5):409-17. doi: 10.1016/j.contraception.2008.06.016. Epub 2008 Sep 18.</citation>
    <PMID>18929739</PMID>
  </reference>
  <reference>
    <citation>Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005 May;71(5):319-26. doi: 10.1016/j.contraception.2004.11.007.</citation>
    <PMID>15854630</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 28, 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>November 20, 2017</last_update_submitted>
  <last_update_submitted_qc>November 20, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Contraceptive implant</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/NCT02986971
org study id: REVALID
nct id: NCT02986971
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
There are no implant removal devices on the market by any manufacturer. New features are
      described in comparison with the existing removal technique. Overall, the RemovAid™ combines
      the features of fixation, incision and extraction. This combination of functions has not
      previously been combined in a single device.

      The investigators wish to perform this pilot clinical investigation with the aim to
      demonstrate that the Investigational Medical Device (IMD), RemovAid ™, may safely and
      effectively facilitate implant removal. Other aims are to show that the IMD have the
      potential to reduce procedure length variability, reduce procedural complexity and reduce the
      need for additional procedural equipment related to CI removal procedures, without causing
      any harm to the subject.
Contraceptive Implants (CIs) were introduced to the commercial market in the early 1980s.
      They are advocated as a safe and effective method of contraception, and are included on the
      WHO's Essential Medicines list.

      CI manufacturers have focused intense efforts on making insertion of CIs easier, but have
      largely left CI removals untouched and at the mercy of the various service providers.
      Different introducers and trocars are available for use with the different CI systems
      available internationally, and a second generation, single-use trocar is supplied with the
      Nexplanon® implant system available in Sweden. This second generation trocar has reduced the
      number of misplaced or deeply inserted CIs, and underlines the benefits of standardizing
      minor surgical procedures through the use of dedicated medical devices.

      The CI removal procedure recommendations have remained essentially unchanged for 40 years,
      relying on scalpels, forceps and general surgical skills from the service provider.
      Currently, no standardized technique for removal of CIs exists, and no dedicated CI removal
      device is found on the commercial market.

      Removal of palpable subdermal implants is generally a simple, minor surgical office
      procedure. However, the procedure for implant removal requires more training and skill than
      the procedure for insertion. There is a risk of slippage of the scalpel blade or a sudden
      movement by the client causing inadvertent deeper penetration, in which case any underlying
      structure could be affected.

      Mean removal times, from time of incision until removal of the rod, are consistently reported
      as less than four minutes, however with ranges from 0.2 - 60 minutes.

      Available research shows that the procedure length of the current CI removal procedure is
      highly variable and reliant on individual operator skills.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Successful removal of implant
time frame: 5 minutes
description: Percentage of fixated implants that were successfully removed without the use of additional tools.
measure: Frequency, severity, causality and outcome of adverse events (AEs)
time frame: 1 week
description: Frequency and severity of sharps injury, nerve damage, blood vessel damage, tissue damage, wound infection and cytotoxicity during and after the use of the device. Performed by investigation of site at the time of operation and one week later.
measure: Pain during procedure
time frame: 5 minutes
description: Mean pain score (maximum pain intensity during the procedure) indicated by the subject on a Visual Analogue Scale (VAS) 0-100 mm ruler, assuming that anaesthesia has been properly administered.
measure: Success of fixation of implant
time frame: 5 minutes
description: Percentage of palpable implants where the implant could be seen and/or felt on both sides of the clamp after maximum three attempts of fixation.
measure: Duration of procedure
time frame: 25 minutes
description: Mean time from
making incision until implant is removed.
first handling the device until closing the wound.
measure: Technical functionality of device determined by an operators questionnaire.
time frame: 5 minutes
description: Fulfilment of pre-defined technical requirements, as documented on an operator functionality questionnaire.
measure: Operators impression of the device
time frame: 5 minutes
description: The operator's global impression of the IMD will be assessed using a 5-point scale.
measure: Subject satisfaction
time frame: 5 minutes
description: The subject's global assessment of satisfaction with the procedure will be assessed using a 5- point scale.
arm group label: New IMD
arm group type: Experimental
description: Subjects with contraceptive implants to be removed, are subjected to the novel device by personnel skilled in traditional removal.
intervention type: Device
intervention name: New IMD
description: The contraceptive implants of the subjects in this arm are removed by the new IMD.
arm group label: New IMD
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marte Bratlie, MD
role: Study Chair
affiliation: RemovAid AS
facility: 
country: Sweden
citation: Committee on Adolescent Health Care Long-Acting Reversible Contraception Working Group, The American College of Obstetricians and Gynecologists. Committee opinion no. 539: adolescents and long-acting reversible contraception: implants and intrauterine devices. Obstet Gynecol. 2012 Oct;120(4):983-8. doi: 10.1097/AOG.0b013e3182723b7d.
PMID: 22996129
citation: World Health Organization. 2014 [cited April 23rd.]; Available from: http://www.who.int/medicines/publications/essentialmedicines/en/
citation: Mansour D, Mommers E, Teede H, Sollie-Eriksen B, Graesslin O, Ahrendt HJ, Gemzell-Danielsson K. Clinician satisfaction and insertion characteristics of a new applicator to insert radiopaque Implanon: an open-label, noncontrolled, multicenter trial. Contraception. 2010 Sep;82(3):243-9. doi: 10.1016/j.contraception.2010.04.007. Epub 2010 May 18.
PMID: 20705152
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: Webb AM. Why go to Tiger Country? A report of two cases of Implanon removal. J Fam Plann Reprod Health Care. 2006 Jul;32(3):193-4. doi: 10.1783/147118906777888233. No abstract available.
PMID: 16857083
citation: Levine JP, Sinofsky FE, Christ MF; Implanon US Study Group. Assessment of Implanon insertion and removal. Contraception. 2008 Nov;78(5):409-17. doi: 10.1016/j.contraception.2008.06.016. Epub 2008 Sep 18.
PMID: 18929739
citation: Funk S, Miller MM, Mishell DR Jr, Archer DF, Poindexter A, Schmidt J, Zampaglione E; Implanon US Study Group. Safety and efficacy of Implanon, a single-rod implantable contraceptive containing etonogestrel. Contraception. 2005 May;71(5):319-26. doi: 10.1016/j.contraception.2004.11.007.
PMID: 15854630
responsible party type: Sponsor
sharing ipd: No