<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/NCT01729988</url>
  </required_header>
  <id_info>
    <org_study_id>CBR-GDAPL-CIBIEM</org_study_id>
    <nct_id>NCT01729988</nct_id>
  </id_info>
  <brief_title>Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study</brief_title>
  <official_title>Carotid Body Removal for the Treatment of Resistant Hypertension: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noblewell</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Noblewell</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to assess the effectiveness, safety and feasibility of carotid body&#xD;
      removal in patients with high blood pressure (hypertension) resistant to medical treatment.&#xD;
      Patients with high blood pressure are at significant risk of medical complications including&#xD;
      stroke and heart disease. The principle research question is whether removal of the carotid&#xD;
      body will lead to an improvement in the blood pressure of this patient group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">January 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Change of Blood Pressure</measure>
    <time_frame>3 months</time_frame>
    <description>Change from Baseline Blood Pressure at 3 months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Hypertension</condition>
  <arm_group>
    <arm_group_label>Carotid body excision</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Carotid body excision</intervention_name>
    <description>This surgery does not involve any study drug or investigational device.&#xD;
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.</description>
    <arm_group_label>Carotid body excision</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Resistant HTN criteria with either confirmed sleep disordered breathing. Definition of&#xD;
             HTN:Office SBP ≥ 160 mmHg and daytime mean ABPM ≥ 140 mm Hg&#xD;
&#xD;
          -  Definition of sleep disordered breathing: SDB defined as mild to moderate obstructive,&#xD;
             central or mixed sleep apnea defined as 5 &lt; AHI &lt; 30 with O2 desaturation not&#xD;
             exceeding 80% during the night.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Calculated GFR &lt; 30&#xD;
&#xD;
          -  Carotid body located outside the defined carotid septum&#xD;
&#xD;
          -  Obstructive carotid atherosclerotic disease&#xD;
&#xD;
          -  Oxygen desaturation at rest below 92%&#xD;
&#xD;
          -  Known structural lung disease (medical interview)&#xD;
&#xD;
          -  Requirement for oxygen therapy to maintain oxygen saturation&#xD;
&#xD;
          -  Patients wish to participate in mountain climbing, skin diving or free diving&#xD;
&#xD;
          -  Pregnancy or anticipation of pregnancy&#xD;
&#xD;
          -  Palliative care/chemotherapy&#xD;
&#xD;
          -  Acute coronary syndrome or unstable angina &lt; 6 months prior to procedure&#xD;
&#xD;
          -  Use of exogenous insulin AND history of hypoglycemic unawareness&#xD;
&#xD;
          -  Stroke or transient ischaemic attack (TIA), or myocardial infarction &lt; 6 months prior&#xD;
             to procedure&#xD;
&#xD;
          -  Expected life expectancy less that 24months due to other disease&#xD;
&#xD;
          -  Intravenous drug use&#xD;
&#xD;
          -  Excessive use of alcohol or sedatives (Alcohol intake &gt;28 units/week)&#xD;
&#xD;
          -  Obesity (BMI &gt; 40)&#xD;
&#xD;
          -  Upper airway or facial abnormalities&#xD;
&#xD;
          -  Large neck circumference (&gt;43.2 cm men; &gt;40.6 cm women)&#xD;
&#xD;
          -  Febrile illness within two weeks of participation&#xD;
&#xD;
          -  Unable to attend for follow up appointments at 1, 3 and 6 months post operatively.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul A. Sobotka, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Cibiem, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Hypertension and Diabetology, Medical University of Gdansk</name>
      <address>
        <city>Gdansk</city>
        <zip>80-952</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>October 14, 2016</last_update_submitted>
  <last_update_submitted_qc>October 14, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypertension</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729988
org study id: CBR-GDAPL-CIBIEM
nct id: NCT01729988
lead sponsor: 
has dmc: Yes
This is a pilot study to assess the effectiveness, safety and feasibility of carotid body
      removal in patients with high blood pressure (hypertension) resistant to medical treatment.
      Patients with high blood pressure are at significant risk of medical complications including
      stroke and heart disease. The principle research question is whether removal of the carotid
      body will lead to an improvement in the blood pressure of this patient group.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of Blood Pressure
time frame: 3 months
description: Change from Baseline Blood Pressure at 3 months
arm group label: Carotid body excision
arm group type: Experimental
description: Patients undergoing the carotid body excision to test the hypothesis that carotid body excision is sufficient to attain target blood pressure.
intervention type: Procedure
intervention name: Carotid body excision
description: This surgery does not involve any study drug or investigational device.
The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation.
arm group label: Carotid body excision
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Paul A. Sobotka, M.D.
role: Study Director
affiliation: Cibiem, Inc.
facility: 
country: Poland
responsible party type: Sponsor
mesh term: Hypertension