xml: <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/NCT05968365</url>
    </required_header>
    <id_info>
      <org_study_id>WKKJ-2020001</org_study_id>
      <nct_id>NCT05968365</nct_id>
    </id_info>
    <brief_title>Evaluate the Safety and Effectiveness of Electronic Vision-aid Device</brief_title>
    <official_title>Clinical Trial of the Safety and Effectiveness of Vision Pro Electronic Blind Aid Device</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Wicab Technologies (Beijing) Co., Ltd.</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Wicab Technologies (Beijing) Co., Ltd.</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and&#xD;
        obstacle recognition for visually blind people&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">February 1, 2021</start_date>
    <completion_date type="Actual">March 31, 2021</completion_date>
    <primary_completion_date type="Actual">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>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <intervention_model_description>The clinical trial was a prospective, single-group, uncontrolled design using the target value method&#xD;
  Three centers participated&#xD;
  A total of 36 patients were enrolled. It was developed and produced by Weikan Technology in subjects who agreed to be enrolled&#xD;
  The &quot;Vision Pro&quot; is trained, and after no less than 3 hours of training, the subject is good at it&#xD;
  Evaluate the safety and effectiveness of obstacle perception and recognition in the process of walking, and evaluate the test product in auxiliary sight&#xD;
  Safety and effectiveness of obstacle perception and recognition for disabled walkers.</intervention_model_description>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>obstacle identification</measure>
      <time_frame>40 minutes</time_frame>
      <description>The success rate of obstacle identification</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>obstacle avoidance test</measure>
      <time_frame>40 minutes</time_frame>
      <description>the success rate of obstacle avoidance</description>
    </secondary_outcome>
    <enrollment type="Actual">36</enrollment>
    <condition>the Blind</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>electronic Vision-aid Device</intervention_name>
      <description>Electronic blind aid is a non-invasive electronic aid product for the visually impaired. The product converts visual signals into tactile signals. The Vision Pro is designed for people with poor or no visual perception. The product does not change the previous travel mode of the visually impaired, and provides additional external information for the visually impaired on the basis of their existing cognition. The product can provide the visually impaired person with additional external information based on the cognition in front of them. The product can feedback the environmental information within 2.52.5 meters in front of the visually impaired person in the form of electrical stimulation to the visually impaired person. The visually impaired person can be stimulated by the tongue current to help them identify obstacles and give early warning. Avoid obstacles and give early warning.</description>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age 18-65 (including 18 and 65 years old)；&#xD;
  &#xD;
            2. Visually impaired people；&#xD;
  &#xD;
            3. Primary blind and visually impaired people&#xD;
  &#xD;
            4. visual acuity is no light ~ &lt; 0.02；&#xD;
  &#xD;
            5. visual field radius less than 5°);&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. . Allergic to nickel or stainless steel;&#xD;
  &#xD;
            2. epileptic seizures;&#xD;
  &#xD;
            3. pregnant women； 4.、implanted with electronic medical devices ；&#xD;
  &#xD;
          5、 intellectual disability ； 6、 mental illness; 7、 Oral diseases； 8、oral ulcers, herpes,&#xD;
          herpes simplex, oral thrush and map tongue； 9、 speech dysfunction, 10、limited mobility and&#xD;
          hearing impairment;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Tongren Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>066004</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>December 2021</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 31, 2023</last_update_submitted>
    <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>ResMan</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968365
  org study id: WKKJ-2020001
  nct id: NCT05968365
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To evaluate the safety and effectiveness of electronic Vision-aid Device in walking and
        obstacle recognition for visually blind people
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: The clinical trial was a prospective, single-group, uncontrolled design using the target value method
  Three centers participated
  A total of 36 patients were enrolled. It was developed and produced by Weikan Technology in subjects who agreed to be enrolled
  The "Vision Pro" is trained, and after no less than 3 hours of training, the subject is good at it
  Evaluate the safety and effectiveness of obstacle perception and recognition in the process of walking, and evaluate the test product in auxiliary sight
  Safety and effectiveness of obstacle perception and recognition for disabled walkers.
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: obstacle identification
  time frame: 40 minutes
  description: The success rate of obstacle identification
  measure: obstacle avoidance test
  time frame: 40 minutes
  description: the success rate of obstacle avoidance
  intervention type: Device
  intervention name: electronic Vision-aid Device
  description: Electronic blind aid is a non-invasive electronic aid product for the visually impaired. The product converts visual signals into tactile signals. The Vision Pro is designed for people with poor or no visual perception. The product does not change the previous travel mode of the visually impaired, and provides additional external information for the visually impaired on the basis of their existing cognition. The product can provide the visually impaired person with additional external information based on the cognition in front of them. The product can feedback the environmental information within 2.52.5 meters in front of the visually impaired person in the form of electrical stimulation to the visually impaired person. The visually impaired person can be stimulated by the tongue current to help them identify obstacles and give early warning. Avoid obstacles and give early warning.
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: China
  responsible party type: Sponsor
  sharing ipd: No
  ipd description: ResMan