<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/NCT04502147</url>
  </required_header>
  <id_info>
    <org_study_id>168/7</org_study_id>
    <nct_id>NCT04502147</nct_id>
  </id_info>
  <brief_title>How to Provide Vascular Control of Splenic Artery Aneurysm? Report of Two Cases</brief_title>
  <official_title>How to Provide Vascular Control of Splenic Artery Aneurysm? Report of Two Cases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tecnologico de Monterrey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tecnologico de Monterrey</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Spleen artery aneurysm represents the most common visceral aneurysm and the third most common&#xD;
      splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other&#xD;
      diagnostic focuses and examinations. The investigators present two patients with splenic&#xD;
      artery aneurysms localized in the splenic hilum, who auspiciously undergo laparoscopic&#xD;
      splenectomies with hem-o-lock clips in the vascular hilum without complications. These two&#xD;
      cases showed that in addition to the numerous advantages of minimally invasive approaches,&#xD;
      there is the possibility to improve laparoscopic technique in terms of safety and economic&#xD;
      reasons by using hem - o - lock clips as a hemostatic technique securing the vascular&#xD;
      elements of the splenic hilum.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">July 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 30, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Arterial Splenic Aneurysm</measure>
    <time_frame>July 2020</time_frame>
    <description>Asses the splenic hilium after operating a splenic arterial aneurysm. It will be measure by the follow up of the patient, by consult and physical examination.</description>
  </primary_outcome>
  <enrollment type="Actual">1</enrollment>
  <condition>Arterial Splenic Aneurysm</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic Splenectomy</intervention_name>
    <description>Laparoscopic splenectomy by ligating the splenic artery</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        41-year-old patient who was diagnosed with splenic artery enlargement on a routine&#xD;
        ultrasound examination.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults patients (&gt;18 year old) with splenic arterial aneurysms&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients younger than 18 years old. Patients without splenic arterial aneurysms&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Tecnologico de Monterrey</name>
      <address>
        <city>Monterrey.</city>
        <state>Nuevo Leon</state>
        <zip>64710</zip>
        <country>Mexico</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Mexico</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tecnologico de Monterrey</investigator_affiliation>
    <investigator_full_name>Alejandro Ruiz Velasco Santacruz</investigator_full_name>
    <investigator_title>Chief of Residents</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aneurysm</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04502147
org study id: 168/7
nct id: NCT04502147
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Spleen artery aneurysm represents the most common visceral aneurysm and the third most common
      splanchnic aneurysm. Most patients have no symptoms and are diagnosed as a part of other
      diagnostic focuses and examinations. The investigators present two patients with splenic
      artery aneurysms localized in the splenic hilum, who auspiciously undergo laparoscopic
      splenectomies with hem-o-lock clips in the vascular hilum without complications. These two
      cases showed that in addition to the numerous advantages of minimally invasive approaches,
      there is the possibility to improve laparoscopic technique in terms of safety and economic
      reasons by using hem - o - lock clips as a hemostatic technique securing the vascular
      elements of the splenic hilum.
observational model: Case-Only
time perspective: Retrospective
measure: Arterial Splenic Aneurysm
time frame: July 2020
description: Asses the splenic hilium after operating a splenic arterial aneurysm. It will be measure by the follow up of the patient, by consult and physical examination.
intervention type: Procedure
intervention name: Laparoscopic Splenectomy
description: Laparoscopic splenectomy by ligating the splenic artery
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Mexico
responsible party type: Principal Investigator
investigator affiliation: Tecnologico de Monterrey
investigator full name: Alejandro Ruiz Velasco Santacruz
investigator title: Chief of Residents
mesh term: Aneurysm
sharing ipd: No