<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/NCT02224001</url>
  </required_header>
  <id_info>
    <org_study_id>Tip Plasty</org_study_id>
    <nct_id>NCT02224001</nct_id>
  </id_info>
  <brief_title>A New Concept in the Tip Plasty of Asian Rhinoplasty</brief_title>
  <acronym>TP</acronym>
  <official_title>A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage Without Septal Extension Grafts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Winners Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Winners Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For achieving the desired refinements in Asian patients, sufficient septal cartilage must be&#xD;
      needed for the ieal tip projection and lengthening of the nose by the septal extension graft,&#xD;
      columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many&#xD;
      cases having insufficient septal cartilages in Asian augmentation rhinoplasty.&#xD;
&#xD;
      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut&#xD;
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar&#xD;
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the&#xD;
      elongated columellar septal strut graft without the septal extension graft to achieve the&#xD;
      desired the result.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut&#xD;
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar&#xD;
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the&#xD;
      elongated columellar septal strut graft without the septal extension graft to achieve the&#xD;
      desired the result.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2008</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with Serious and Non-Serious Adverse Events</measure>
    <time_frame>six months</time_frame>
    <description>tip deviation : 1 case&#xD;
low tip projection : 1 case</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">161</enrollment>
  <condition>Asian Rhinoplasty</condition>
  <arm_group>
    <arm_group_label>Asian rhinoplasty, septal cartilage</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts&#xD;
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>The Flag Technique</intervention_name>
    <description>A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts&#xD;
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.</description>
    <arm_group_label>Asian rhinoplasty, septal cartilage</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  primary case&#xD;
&#xD;
          -  secondary case&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  septal cartilage harvested state&#xD;
&#xD;
          -  congenital anomaly in septal cartilage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>CHEOLHWAN KIM, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Winners Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Department of Plastic Surgery, Winners Clinic</name>
      <address>
        <city>Gangnamgu</city>
        <state>Seoul</state>
        <zip>135-893</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <reference>
    <citation>1.Toriumi, D.M. Augmentation rhinoplasty with autologous cartilage grafting. In Park JI, Toriumi, D.M., eds. Asian Facial Cosmetic Surgery. Philadelphia: Saunders-Elsvier, 2007. 2.Toriumi, D.M. Autologous grafts are worth the extra time. Arch Otolaryngol Head Neck Surg 126:562-564, 2000. 3.Toriumi, D.M., DeRosa J. The Asian nose. In R. J. Rohrich, W. P. Jr. Adams, and J. Ahmad, J. P. Gunter (Eds.), Dallas Rhinoplasty: Nasal Surgery by the Masters, Vol 2, 3rd Ed. St. Louise: Quality Medical, 2014. Pp. 1226-1229. 4.Byrd , H.S., Burt, J.D., Andochick, S., et al. Septal extension grafts: a method for controlling tip projection and shape. Plast Reconstr Surg 100:999-1010, 1997. 5.Rohrich R.J., Kurkjian T.J., Hoxworth R.E., et al. The effect of the columellar strut graft on the nasal tip position in primary rhinoplasty. Plast Reconstr Surg 130:926-932, 2012. Erratum in Plast Reconstr Surg 130:1399, 2012.</citation>
  </reference>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>August 21, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <last_update_submitted>September 11, 2014</last_update_submitted>
  <last_update_submitted_qc>September 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>tip plasty</keyword>
  <keyword>septal cartilage</keyword>
  <!-- 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/NCT02224001
org study id: Tip Plasty
nct id: NCT02224001
lead sponsor: 
has dmc: No
For achieving the desired refinements in Asian patients, sufficient septal cartilage must be
      needed for the ieal tip projection and lengthening of the nose by the septal extension graft,
      columellar septal strut graft, and onlay tip graft, shield graft. Actually there are many
      cases having insufficient septal cartilages in Asian augmentation rhinoplasty.

      The investigators propose the new technique, so called 'Flag Technique' by a tip-strut
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the
      elongated columellar septal strut graft without the septal extension graft to achieve the
      desired the result.
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut
      complex in a flag-like shape : using only the septal cartilage as an elongated columellar
      septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the
      elongated columellar septal strut graft without the septal extension graft to achieve the
      desired the result.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with Serious and Non-Serious Adverse Events
time frame: six months
description: tip deviation : 1 case
low tip projection : 1 case
arm group label: Asian rhinoplasty, septal cartilage
arm group type: Experimental
description: A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
intervention type: Procedure
intervention name: The Flag Technique
description: A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result.
arm group label: Asian rhinoplasty, septal cartilage
criteria: 
gender: All
minimum age: 17 Years
maximum age: 74 Years
healthy volunteers: Accepts Healthy Volunteers
last name: CHEOLHWAN KIM, MD
role: Principal Investigator
affiliation: Winners Clinic
facility: 
country: Korea, Republic of
citation: 1.Toriumi, D.M. Augmentation rhinoplasty with autologous cartilage grafting. In Park JI, Toriumi, D.M., eds. Asian Facial Cosmetic Surgery. Philadelphia: Saunders-Elsvier, 2007. 2.Toriumi, D.M. Autologous grafts are worth the extra time. Arch Otolaryngol Head Neck Surg 126:562-564, 2000. 3.Toriumi, D.M., DeRosa J. The Asian nose. In R. J. Rohrich, W. P. Jr. Adams, and J. Ahmad, J. P. Gunter (Eds.), Dallas Rhinoplasty: Nasal Surgery by the Masters, Vol 2, 3rd Ed. St. Louise: Quality Medical, 2014. Pp. 1226-1229. 4.Byrd , H.S., Burt, J.D., Andochick, S., et al. Septal extension grafts: a method for controlling tip projection and shape. Plast Reconstr Surg 100:999-1010, 1997. 5.Rohrich R.J., Kurkjian T.J., Hoxworth R.E., et al. The effect of the columellar strut graft on the nasal tip position in primary rhinoplasty. Plast Reconstr Surg 130:926-932, 2012. Erratum in Plast Reconstr Surg 130:1399, 2012.
responsible party type: Sponsor