<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/NCT01679223</url>
  </required_header>
  <id_info>
    <org_study_id>081512</org_study_id>
    <nct_id>NCT01679223</nct_id>
  </id_info>
  <brief_title>Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12</brief_title>
  <official_title>Objective Evaluation of Collagen Deposition in AlloMaxTM Acellular Dermal Matrix in Breast Reconstruction Version 8-15-12</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nevada, Las Vegas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nevada, Las Vegas</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to measure the level of AlloMax™ incorporation (cellular&#xD;
      infiltration, collagen production, and neovascularization) in human breast reconstruction.&#xD;
      The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast&#xD;
      capsule at the 3-4 month time point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2014</start_date>
  <completion_date type="Anticipated">November 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hydroxyproline Concentration</measure>
    <time_frame>3-4 months</time_frame>
    <description>Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neoangiogenesis</measure>
    <time_frame>3-4 months</time_frame>
    <description>Measure new blood vessels in AlloMaxTM and adjacent capsule</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Collagen I and III</measure>
    <time_frame>3-4 months</time_frame>
    <description>Measure collagen I and III in AlloMaxTM and adjacent capsule</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>&lt;40 years</arm_group_label>
    <description>subjects aged less than 40 years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>40-60 years</arm_group_label>
    <description>subjects aged 40-60years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>&gt; 60 years</arm_group_label>
    <description>subjects aged greater than 60 years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with&#xD;
        AlloMaxTM are potential subjects for this study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM&#xD;
             implants and agree to participate will be included in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who do not agree to be included in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kayvan Taghipour-Khiabani, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Nevada School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>William A Zamboni, M.D.</last_name>
    <role>Study Chair</role>
    <affiliation>University of Nevada School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kayvan Taghipour-Khiabani, M.D.</last_name>
    <phone>702-671-2267</phone>
    <email>kkhiabani@medicine.nevada.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shelley J Williams, M.S.</last_name>
    <phone>702-895-1445</phone>
    <email>sjwilliams@medicine.nevada.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Nevada School of Medicine</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102-2227</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sherree Mounts, LPN</last_name>
      <phone>702-671-5117</phone>
      <email>smounts@medicine.nevada.edu</email>
    </contact>
    <investigator>
      <last_name>Kayvan Taghipour-Khiabani, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>William A Zamboni, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Richard C Baynosa, M.D.</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2012</study_first_posted>
  <last_update_submitted>January 8, 2015</last_update_submitted>
  <last_update_submitted_qc>January 8, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 9, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nevada, Las Vegas</investigator_affiliation>
    <investigator_full_name>Kayvan Taghipour-Khiabani, M.D.</investigator_full_name>
    <investigator_title>Tenured Associate Professor, Head of Hand and Microsurgery</investigator_title>
  </responsible_party>
  <keyword>Breast reconstruction</keyword>
  <keyword>Hydroxyproline concentration</keyword>
  <keyword>neoangiogenesis</keyword>
  <keyword>collagen deposition</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/NCT01679223
org study id: 081512
nct id: NCT01679223
lead sponsor: 
has dmc: No
The purpose of this study is to measure the level of AlloMax™ incorporation (cellular
      infiltration, collagen production, and neovascularization) in human breast reconstruction.
      The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast
      capsule at the 3-4 month time point.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Hydroxyproline Concentration
time frame: 3-4 months
description: Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.
measure: Neoangiogenesis
time frame: 3-4 months
description: Measure new blood vessels in AlloMaxTM and adjacent capsule
measure: Collagen I and III
time frame: 3-4 months
description: Measure collagen I and III in AlloMaxTM and adjacent capsule
arm group label: <40 years
description: subjects aged less than 40 years
arm group label: 40-60 years
description: subjects aged 40-60years
arm group label: > 60 years
description: subjects aged greater than 60 years
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Kayvan Taghipour-Khiabani, M.D.
role: Principal Investigator
affiliation: University of Nevada School of Medicine
last name: William A Zamboni, M.D.
role: Study Chair
affiliation: University of Nevada School of Medicine
last name: Kayvan Taghipour-Khiabani, M.D.
phone: 702-671-2267
email: kkhiabani@medicine.nevada.edu
last name: Shelley J Williams, M.S.
phone: 702-895-1445
email: sjwilliams@medicine.nevada.edu
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Nevada, Las Vegas
investigator full name: Kayvan Taghipour-Khiabani, M.D.
investigator title: Tenured Associate Professor, Head of Hand and Microsurgery