<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/NCT03790956</url>
  </required_header>
  <id_info>
    <org_study_id>APP-18-05229</org_study_id>
    <nct_id>NCT03790956</nct_id>
  </id_info>
  <brief_title>Silk Protein Microparticle-based Filler for Injection Augmentation</brief_title>
  <official_title>Safety and Efficacy of a Silk Protein Microparticle-based Filler for Injection Augmentation in Treating Unilateral Vocal Fold Paralysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sofregen Medical, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Southern California</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will investigate the safety and efficacy of a silk protein microparticle-based&#xD;
      filler for vocal fold injection augmentation to treat dysphonia/dysphagia secondary to vocal&#xD;
      fold paralysis. Participants will receive one injection and follow-up for a planned period of&#xD;
      12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vocal fold paralysis is a clinical condition that arises commonly as a complication of&#xD;
      surgery, endotracheal intubation, malignancy, or idiopathic etiologies. It often results in&#xD;
      glottal insufficiency, which is the inability of the true vocal folds to meet and achieve&#xD;
      complete closure during normal physiologic functions such as speech, swallowing, and&#xD;
      coughing. The presence of vocal fold paralysis with glottal insufficiency can lead to&#xD;
      decreased quality-of-life, as well as increase risks of complications such as aspiration&#xD;
      pneumonia.&#xD;
&#xD;
      Current treatments for vocal fold paralysis are based around techniques to medialize the&#xD;
      paralyzed vocal fold. One manner in which this is done is via injection of a filler or&#xD;
      bulking agent into the vocal fold in order to augment it. Injection augmentation has many&#xD;
      advantages including its minimally invasive nature, overall safety and low risk/complication&#xD;
      rate, immediate clinical effect, and ability to perform it at the bedside or in-office.&#xD;
      Various materials are used for injection augmentation including autologous fat, hyaluronic&#xD;
      acid, collagen, carboxymethylcellulose, and calcium hydroxyapatite. However, all of the&#xD;
      current injection choices have individual limitations such as temporary effect,&#xD;
      unpredictability due to variable resorption by the body, unfavorable mechanical properties,&#xD;
      and challenging handling attributes.&#xD;
&#xD;
      Silk is derived from the Bombyx mori silk worm and has a long history as a surgical&#xD;
      biomaterial. Surgical scaffolds derived from silk have been used for reconstructive surgery,&#xD;
      due to its ability to allow cellular infiltration and encourage tissue&#xD;
      regeneration/remodeling. Given the potential advantages of such a material, Brown et al&#xD;
      engineered and studied a novel silk protein microparticle-based filler material suitable for&#xD;
      injection augmentation.&#xD;
&#xD;
      Patients with unilateral vocal fold paralysis identified at the study sites will be offered&#xD;
      participation in this study to receive injection augmentation of the paralyzed vocal fold&#xD;
      with the filler material under investigation. Outcome measures evaluated pre- and&#xD;
      post-injection and over follow-up visits will include various patient reported quality of&#xD;
      life indices, objective clinical assessments of voice, laryngeal videostroboscopy&#xD;
      examinations, and acoustic/aerodynamic testing. The investigators hypothesize that the novel&#xD;
      silk protein microparticle-based filler will have a favorable safety profile for use as an&#xD;
      injectable material in the human larynx and it will produce durable clinical benefit lasting&#xD;
      up to 12 months.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">March 15, 2023</completion_date>
  <primary_completion_date type="Actual">March 15, 2023</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>
    <intervention_model_description>Single vocal fold injection of study material with possible booster injection, and follow-up of 12 months post injection.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale</measure>
    <time_frame>12 months</time_frame>
    <description>Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by Voice Handicap Index-10 (VHI-10)</measure>
    <time_frame>12 months</time_frame>
    <description>VHI-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by Vocal Fatigue Index (VFI)</measure>
    <time_frame>12 months</time_frame>
    <description>VFI is a patient questionnaire with 19 statements rated from 0-4 with overall scale 0-76.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by Dyspnea Index (DI)</measure>
    <time_frame>12 months</time_frame>
    <description>DI is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life as assessed by Eating Assessment Tool (EAT-10)</measure>
    <time_frame>12 months</time_frame>
    <description>EAT-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument</measure>
    <time_frame>12 months</time_frame>
    <description>Blinded evaluations of audio voice recordings will be performed by laryngologists and speech-language pathologists using the CAPE-V, which grades overall severity, roughness, breathiness, strain, pitch, and loudness from 0-100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form</measure>
    <time_frame>12 months</time_frame>
    <description>Blinded assessments of recorded laryngeal videostroboscopy exams will be performed by laryngologists and speech-language pathologists using a modified version of the VALI, which is a graphical rating form to grade various components seen on stroboscopy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Acoustic Testing as assessed by fundamental frequency</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of fundamental frequency (F0) during sustained vowel phonation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Acoustic Testing as assessed by Sound Pressure Level (SPL)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of minimum/maximum SPL during phonation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Acoustic Testing as assessed by Cepstral Peak Prominence (CPP)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of CPP during phonation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Aerodynamic Testing as assessed by Vital Capacity (VC)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of VC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Aerodynamic Testing as assessed by Maximum Phonation Time (MPT)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of MPT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Aerodynamic Testing as assessed by Mean Glottal Flow Rate (MGFR)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of MGFR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Aerodynamic Testing as assessed by Subglottal Pressure (SGP)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of SGP.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Aerodynamic Testing as assessed by Cough Velocity (CV)</measure>
    <time_frame>12 months</time_frame>
    <description>Measurement of maximum CV.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Vocal Cord Paralysis Unilateral</condition>
  <condition>Dysphonia</condition>
  <condition>Dysphagia, Oropharyngeal</condition>
  <arm_group>
    <arm_group_label>Silk Microparticle Filler Injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Silk Microparticle Filler Injection</intervention_name>
    <description>A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.</description>
    <arm_group_label>Silk Microparticle Filler Injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral vocal fold immobility with glottal insufficiency present for at least 2&#xD;
             weeks from onset&#xD;
&#xD;
          -  Willingness to partake in study and follow-up as documented by signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allergy/hypersensitivity to silk or silk containing products&#xD;
&#xD;
          -  History of allergy/hypersensitivity to hyaluronic acid (HA) or HA containing products&#xD;
&#xD;
          -  History of allergy/hypersensitivity to lidocaine or amide-based anesthetics&#xD;
&#xD;
          -  History of an autoimmune condition&#xD;
&#xD;
          -  Significant immunocompromised state (i.e. immunosuppression s/p transplantation)&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Active infection or inflammation in the larynx&#xD;
&#xD;
          -  Comorbid known laryngeal conditions including but not limited to vocal fold scar,&#xD;
             vocal tremor, laryngeal dystonia, etc. that would warrant other interventions for&#xD;
             optimal treatment&#xD;
&#xD;
          -  History of laryngeal surgery&#xD;
&#xD;
          -  Life expectancy of less than 6 months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Spector BC, Netterville JL, Billante C, Clary J, Reinisch L, Smith TL. Quality-of-life assessment in patients with unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 2001 Sep;125(3):176-82. doi: 10.1067/mhn.2001.117714.</citation>
    <PMID>11555751</PMID>
  </reference>
  <reference>
    <citation>Brown JE, Gulka CP, Giordano JEM, Montero MP, Hoang A, Carroll TL. Injectable Silk Protein Microparticle-based Fillers: A Novel Material for Potential Use in Glottic Insufficiency. J Voice. 2019 Sep;33(5):773-780. doi: 10.1016/j.jvoice.2018.01.017. Epub 2018 Mar 30.</citation>
    <PMID>29609905</PMID>
  </reference>
  <reference>
    <citation>Etienne O, Schneider A, Kluge JA, Bellemin-Laponnaz C, Polidori C, Leisk GG, Kaplan DL, Garlick JA, Egles C. Soft tissue augmentation using silk gels: an in vitro and in vivo study. J Periodontol. 2009 Nov;80(11):1852-8. doi: 10.1902/jop.2009.090231.</citation>
    <PMID>19905955</PMID>
  </reference>
  <reference>
    <citation>Bellas E, Panilaitis BJ, Glettig DL, Kirker-Head CA, Yoo JJ, Marra KG, Rubin JP, Kaplan DL. Sustained volume retention in vivo with adipocyte and lipoaspirate seeded silk scaffolds. Biomaterials. 2013 Apr;34(12):2960-8. doi: 10.1016/j.biomaterials.2013.01.058. Epub 2013 Jan 29.</citation>
    <PMID>23374707</PMID>
  </reference>
  <reference>
    <citation>Kijanska M, Marmaras A, Hegglin A, Kurtcuoglu V, Giovanoli P, Lindenblatt N. In vivo characterization of the integration and vascularization of a silk-derived surgical scaffold. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):1141-50. doi: 10.1016/j.bjps.2016.01.017. Epub 2016 Feb 5.</citation>
    <PMID>26966076</PMID>
  </reference>
  <reference>
    <citation>Rosen CA, Gartner-Schmidt J, Casiano R, Anderson TD, Johnson F, Remacle M, Sataloff RT, Abitbol J, Shaw G, Archer S, Zraick RI. Vocal fold augmentation with calcium hydroxylapatite: twelve-month report. Laryngoscope. 2009 May;119(5):1033-41. doi: 10.1002/lary.20126.</citation>
    <PMID>19274731</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>November 25, 2018</study_first_submitted>
  <study_first_submitted_qc>December 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 2, 2019</study_first_posted>
  <last_update_submitted>May 8, 2023</last_update_submitted>
  <last_update_submitted_qc>May 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Southern California</investigator_affiliation>
    <investigator_full_name>Michael Johns</investigator_full_name>
    <investigator_title>Professor, Otolaryngology-Head and Neck Surgery; Director, USC Voice Center</investigator_title>
  </responsible_party>
  <keyword>vocal fold paralysis</keyword>
  <keyword>glottal insufficiency</keyword>
  <keyword>vocal fold injection</keyword>
  <keyword>augmentation</keyword>
  <keyword>medialization</keyword>
  <keyword>laryngoplasty</keyword>
  <keyword>silk</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Deglutition Disorders</mesh_term>
    <mesh_term>Dysphonia</mesh_term>
    <mesh_term>Vocal Cord Paralysis</mesh_term>
    <mesh_term>Paralysis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790956
org study id: APP-18-05229
nct id: NCT03790956
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will investigate the safety and efficacy of a silk protein microparticle-based
      filler for vocal fold injection augmentation to treat dysphonia/dysphagia secondary to vocal
      fold paralysis. Participants will receive one injection and follow-up for a planned period of
      12 months.
Vocal fold paralysis is a clinical condition that arises commonly as a complication of
      surgery, endotracheal intubation, malignancy, or idiopathic etiologies. It often results in
      glottal insufficiency, which is the inability of the true vocal folds to meet and achieve
      complete closure during normal physiologic functions such as speech, swallowing, and
      coughing. The presence of vocal fold paralysis with glottal insufficiency can lead to
      decreased quality-of-life, as well as increase risks of complications such as aspiration
      pneumonia.

      Current treatments for vocal fold paralysis are based around techniques to medialize the
      paralyzed vocal fold. One manner in which this is done is via injection of a filler or
      bulking agent into the vocal fold in order to augment it. Injection augmentation has many
      advantages including its minimally invasive nature, overall safety and low risk/complication
      rate, immediate clinical effect, and ability to perform it at the bedside or in-office.
      Various materials are used for injection augmentation including autologous fat, hyaluronic
      acid, collagen, carboxymethylcellulose, and calcium hydroxyapatite. However, all of the
      current injection choices have individual limitations such as temporary effect,
      unpredictability due to variable resorption by the body, unfavorable mechanical properties,
      and challenging handling attributes.

      Silk is derived from the Bombyx mori silk worm and has a long history as a surgical
      biomaterial. Surgical scaffolds derived from silk have been used for reconstructive surgery,
      due to its ability to allow cellular infiltration and encourage tissue
      regeneration/remodeling. Given the potential advantages of such a material, Brown et al
      engineered and studied a novel silk protein microparticle-based filler material suitable for
      injection augmentation.

      Patients with unilateral vocal fold paralysis identified at the study sites will be offered
      participation in this study to receive injection augmentation of the paralyzed vocal fold
      with the filler material under investigation. Outcome measures evaluated pre- and
      post-injection and over follow-up visits will include various patient reported quality of
      life indices, objective clinical assessments of voice, laryngeal videostroboscopy
      examinations, and acoustic/aerodynamic testing. The investigators hypothesize that the novel
      silk protein microparticle-based filler will have a favorable safety profile for use as an
      injectable material in the human larynx and it will produce durable clinical benefit lasting
      up to 12 months.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single vocal fold injection of study material with possible booster injection, and follow-up of 12 months post injection.
primary purpose: Treatment
masking: None (Open Label)
measure: Incidence of Treatment-Emergent Adverse Events as assessed by FDA/CBER Adverse Event Severity Grading Scale
time frame: 12 months
description: Adverse event severity grading scale from 1 to 4, with grade 1 as mild, grade 2 as moderate, grade 3 as severe, and grade 4 potentially life-threatening.
measure: Quality of Life as assessed by Voice Handicap Index-10 (VHI-10)
time frame: 12 months
description: VHI-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.
measure: Quality of Life as assessed by Vocal Fatigue Index (VFI)
time frame: 12 months
description: VFI is a patient questionnaire with 19 statements rated from 0-4 with overall scale 0-76.
measure: Quality of Life as assessed by Dyspnea Index (DI)
time frame: 12 months
description: DI is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.
measure: Quality of Life as assessed by Eating Assessment Tool (EAT-10)
time frame: 12 months
description: EAT-10 is a patient questionnaire with 10 statements rated from 0 to 4 with overall scale 0-40.
measure: Objective Vocal Quality as assessed by experts using the Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) instrument
time frame: 12 months
description: Blinded evaluations of audio voice recordings will be performed by laryngologists and speech-language pathologists using the CAPE-V, which grades overall severity, roughness, breathiness, strain, pitch, and loudness from 0-100.
measure: Vocal Fold Appearance as assessed by experts using a modified version of the Voice-Vibratory Assessment with Laryngeal Imaging (VALI) form
time frame: 12 months
description: Blinded assessments of recorded laryngeal videostroboscopy exams will be performed by laryngologists and speech-language pathologists using a modified version of the VALI, which is a graphical rating form to grade various components seen on stroboscopy.
measure: Objective Acoustic Testing as assessed by fundamental frequency
time frame: 12 months
description: Measurement of fundamental frequency (F0) during sustained vowel phonation.
measure: Objective Acoustic Testing as assessed by Sound Pressure Level (SPL)
time frame: 12 months
description: Measurement of minimum/maximum SPL during phonation.
measure: Objective Acoustic Testing as assessed by Cepstral Peak Prominence (CPP)
time frame: 12 months
description: Measurement of CPP during phonation.
measure: Objective Aerodynamic Testing as assessed by Vital Capacity (VC)
time frame: 12 months
description: Measurement of VC.
measure: Objective Aerodynamic Testing as assessed by Maximum Phonation Time (MPT)
time frame: 12 months
description: Measurement of MPT.
measure: Objective Aerodynamic Testing as assessed by Mean Glottal Flow Rate (MGFR)
time frame: 12 months
description: Measurement of MGFR.
measure: Objective Aerodynamic Testing as assessed by Subglottal Pressure (SGP)
time frame: 12 months
description: Measurement of SGP.
measure: Objective Aerodynamic Testing as assessed by Cough Velocity (CV)
time frame: 12 months
description: Measurement of maximum CV.
arm group label: Silk Microparticle Filler Injection
arm group type: Experimental
description: A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.
intervention type: Procedure
intervention name: Silk Microparticle Filler Injection
description: A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.
arm group label: Silk Microparticle Filler Injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Spector BC, Netterville JL, Billante C, Clary J, Reinisch L, Smith TL. Quality-of-life assessment in patients with unilateral vocal cord paralysis. Otolaryngol Head Neck Surg. 2001 Sep;125(3):176-82. doi: 10.1067/mhn.2001.117714.
PMID: 11555751
citation: Brown JE, Gulka CP, Giordano JEM, Montero MP, Hoang A, Carroll TL. Injectable Silk Protein Microparticle-based Fillers: A Novel Material for Potential Use in Glottic Insufficiency. J Voice. 2019 Sep;33(5):773-780. doi: 10.1016/j.jvoice.2018.01.017. Epub 2018 Mar 30.
PMID: 29609905
citation: Etienne O, Schneider A, Kluge JA, Bellemin-Laponnaz C, Polidori C, Leisk GG, Kaplan DL, Garlick JA, Egles C. Soft tissue augmentation using silk gels: an in vitro and in vivo study. J Periodontol. 2009 Nov;80(11):1852-8. doi: 10.1902/jop.2009.090231.
PMID: 19905955
citation: Bellas E, Panilaitis BJ, Glettig DL, Kirker-Head CA, Yoo JJ, Marra KG, Rubin JP, Kaplan DL. Sustained volume retention in vivo with adipocyte and lipoaspirate seeded silk scaffolds. Biomaterials. 2013 Apr;34(12):2960-8. doi: 10.1016/j.biomaterials.2013.01.058. Epub 2013 Jan 29.
PMID: 23374707
citation: Kijanska M, Marmaras A, Hegglin A, Kurtcuoglu V, Giovanoli P, Lindenblatt N. In vivo characterization of the integration and vascularization of a silk-derived surgical scaffold. J Plast Reconstr Aesthet Surg. 2016 Aug;69(8):1141-50. doi: 10.1016/j.bjps.2016.01.017. Epub 2016 Feb 5.
PMID: 26966076
citation: Rosen CA, Gartner-Schmidt J, Casiano R, Anderson TD, Johnson F, Remacle M, Sataloff RT, Abitbol J, Shaw G, Archer S, Zraick RI. Vocal fold augmentation with calcium hydroxylapatite: twelve-month report. Laryngoscope. 2009 May;119(5):1033-41. doi: 10.1002/lary.20126.
PMID: 19274731
responsible party type: Principal Investigator
investigator affiliation: University of Southern California
investigator full name: Michael Johns
investigator title: Professor, Otolaryngology-Head and Neck Surgery; Director, USC Voice Center
mesh term: Deglutition Disorders
mesh term: Dysphonia
mesh term: Vocal Cord Paralysis
mesh term: Paralysis
sharing ipd: Undecided