<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/NCT04455035</url>
  </required_header>
  <id_info>
    <org_study_id>HSC-DB-20-0311</org_study_id>
    <nct_id>NCT04455035</nct_id>
  </id_info>
  <brief_title>DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants</brief_title>
  <official_title>DynaCleft® Effects on Soft Tissues and on Quality of Life for Incomplete Unilateral Cleft Lip Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center, Houston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center, Houston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft&#xD;
      tissues of infants with unilateral incomplete cleft lip and to assess influences on quality&#xD;
      of life for infants who underwent DynaCleft® and that of their families.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">September 21, 2020</start_date>
  <completion_date type="Anticipated">June 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2021</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>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs</measure>
    <time_frame>initial time of examination with study team, time of surgery(3 months post intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs</measure>
    <time_frame>initial time of examination with study team, time of surgery(3 months post intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs</measure>
    <time_frame>initial time of examination with study team, time of surgery(3 months post intervention)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs</measure>
    <time_frame>initial time of examination with study team, time of surgery(3 months post intervention)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire</measure>
    <time_frame>initial time of examination with study team</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire</measure>
    <time_frame>time of surgery(3 months post intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Cleft Lip and Palate</condition>
  <arm_group>
    <arm_group_label>Retrospective Group(Control)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Prospective Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Comparator: Retrospective Group(Control)</intervention_name>
    <description>The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.</description>
    <arm_group_label>Retrospective Group(Control)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Prospective Group</intervention_name>
    <description>The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.&#xD;
DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.&#xD;
Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.</description>
    <arm_group_label>Prospective Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Retrospective Group:&#xD;
&#xD;
          -  Unilateral cleft lip with or without cleft palate&#xD;
&#xD;
          -  Patients of a single surgeon (Matthew Greives, MD)&#xD;
&#xD;
          -  Patients with complete photographs:&#xD;
&#xD;
               -  After birth, first visit&#xD;
&#xD;
               -  At cleft lip repair (3-4 months)&#xD;
&#xD;
               -  Post-operative cleft repair (about 1 year of age)&#xD;
&#xD;
        Prospective Group:&#xD;
&#xD;
          -  Patients with incomplete unilateral cleft lip with or without cleft palate&#xD;
&#xD;
          -  Patients of any surgeon&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Retrospective Group:&#xD;
&#xD;
          -  Bilateral cleft lip or complete unilateral cleft lip&#xD;
&#xD;
          -  Patients operated on by other primary surgeons&#xD;
&#xD;
          -  Patients with incomplete photo records will be evaluated to determine if the patient&#xD;
             should be excluded&#xD;
&#xD;
        Prospective Group:&#xD;
&#xD;
          -  Patients with bilateral cleft lip or complete unilateral cleft lip&#xD;
&#xD;
          -  Patients whose parents refuse to consent to inclusion&#xD;
&#xD;
          -  Patients with tape allergies to the adhesive of the DynaCleft®&#xD;
&#xD;
          -  Patients with syndromic craniofacial conditions or Tessier type facial clefts&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ahn Tran, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of Texas Health Science Center, Houston</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ahn Tran, DDS</last_name>
    <phone>(713) 486-4150</phone>
    <email>Anh.T.Tran@uth.tmc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Audrena Hankins</last_name>
    <phone>(713) 486-2576</phone>
    <email>Audrena.Hankins@uth.tmc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The University of Texas Health Science Center at Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Anh Tran, DDs</last_name>
      <phone>713-486-4150</phone>
      <email>Anh.T.Tran@uth.tmc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Audrena Hankins</last_name>
      <phone>(713) 486-2576</phone>
      <email>Audrena.Hankins@uth.tmc.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
    <investigator_full_name>Anh T Tran</investigator_full_name>
    <investigator_title>Pediatric Dentistry Resident</investigator_title>
  </responsible_party>
  <keyword>Dynacleft</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Lip</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 31, 2022</submitted>
    <returned>April 28, 2022</returned>
    <submitted>May 17, 2022</submitted>
    <returned>June 9, 2022</returned>
  </pending_results>
  <!-- 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/NCT04455035
org study id: HSC-DB-20-0311
nct id: NCT04455035
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to examine the effectiveness of the DynaCleft® system on soft
      tissues of infants with unilateral incomplete cleft lip and to assess influences on quality
      of life for infants who underwent DynaCleft® and that of their families.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Changes in soft tissue as indicated by columellar angle measured from extraoral clinical photographs
time frame: initial time of examination with study team, time of surgery(3 months post intervention)
measure: Changes in soft tissue as indicated by nostril width measured from extraoral clinical photographs
time frame: initial time of examination with study team, time of surgery(3 months post intervention)
measure: Changes in soft tissue as indicated by nostril height measured from extraoral clinical photographs
time frame: initial time of examination with study team, time of surgery(3 months post intervention)
measure: Changes in soft tissue as indicated by width of the cleft lip measured from extraoral clinical photographs
time frame: initial time of examination with study team, time of surgery(3 months post intervention)
measure: Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
time frame: initial time of examination with study team
measure: Quality of life assessment utilizing an Infant and New Parent Quality of Life questionnaire
time frame: time of surgery(3 months post intervention)
arm group label: Retrospective Group(Control)
arm group type: Active Comparator
arm group label: Prospective Group
arm group type: Experimental
intervention type: Other
intervention name: Comparator: Retrospective Group(Control)
description: The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
arm group label: Retrospective Group(Control)
intervention type: Device
intervention name: Prospective Group
description: The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.
DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.
Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles.
arm group label: Prospective Group
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Ahn Tran, DDS
role: Principal Investigator
affiliation: The University of Texas Health Science Center, Houston
last name: Ahn Tran, DDS
phone: (713) 486-4150
email: Anh.T.Tran@uth.tmc.edu
last name: Audrena Hankins
phone: (713) 486-2576
email: Audrena.Hankins@uth.tmc.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center, Houston
investigator full name: Anh T Tran
investigator title: Pediatric Dentistry Resident
mesh term: Cleft Lip
sharing ipd: No
submitted: March 31, 2022
returned: April 28, 2022
submitted: May 17, 2022
returned: June 9, 2022