<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20190624043991N3</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2019-12-31</date_registration>
      <primary_sponsor>Tehran University of Medical Sciences</primary_sponsor>
      <public_title>Comparison of RIRS (Retrograde Intrarenal Surgery) by Under Vision and Under Fluoroscopic Injection</public_title>
      <acronym>RIRS (Retrograde Intrarenal Surgery)</acronym>
      <scientific_title>Comparison of RIRS (Retrograde Intrarenal Surgery) by Under Vision and Under Fluoroscopic Injection In patients, the candidate is RIRS</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-11-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>118</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/40567</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization method used will be simple randomization. And the random number table will be used. If a number is randomly selected we will move to the right according to the preset contract and if the number even comes in The patient will be admitted to the intervention group and if the number comes in, the patient will be included in the second group (Assigning patients under Under Vision and Under Fluoroscopic Injection based on couple and individual referral number), Blinding description: Patients who have agreed to participate in the study will undergo RIRS in either of two ways, Under Vision or Fluoroscopic Guidance. Participants are unaware of the RIRS procedure.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Urethral stone.</hc_freetext>
      <i_freetext>Intervention 1: RIRS (Retrograde Intrarenal Surgery) performed with a flexibile ureterorenoscope is one of the new methods used to treat urinary stones.                                                                                                                                                      Intervention group:Under Vision(New method as an alternative to fluoroscopy). Intervention 2: RIRS (Retrograde Intrarenal Surgery) performed with a flexible ureterorenoscopy is one of the new methods used to treat urinary stones.                                           Intervention group:Under Fluoroscopic Injection:  Fluoroscopic guides are a useful and effective method of determining the correct position of the needle. Fluoroscopy is a simple and accessible tool that can be used in all pain control procedures during surgery.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
demographic information anonymously

When:
one year after publication

To whom:
registrant

Conditions:
Re-information for the purpose of clarification

Where to obtain:
Dr Seyed Mohammad Kazem Aghamir

How to obtain:
After the examination, the applicant will be provided with the advice of an epidemiologist and with the confidentiality of patient information.

Comments:
-</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr Akram Mirzaei</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urology Research Center- Sina Hospital - Imam Khomeini St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8560</telephone>
        <email>mirzaee.scholar@gmail.com</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr Mohammad Kazem Aghamir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urology Research Center- Sina Hospital - Imam Khomeini St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1136746911</zip>
        <telephone>+98 21 6634 8560</telephone>
        <email>mkaghamir@tums.ac.ir</email>
        <affiliation>Tehran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients who have stones of between 1 and 2 cm in the middle of the upper ciliary and pelvic cavities and below 1 cm inches of lower calis.
Stones that have not responded to ESWL treatment</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>no limit</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Patients affected by hemorrhagic diseases</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N21</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Calculus of lower urinary tract</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>RIRS (Retrograde Intrarenal Surgery) performed with a flexibile ureterorenoscope is one of the new methods used to treat urinary stones.                                                                                                                                                      Intervention group:Under Vision(New method as an alternative to fluoroscopy)</i_keyword>
      <i_keyword>RIRS (Retrograde Intrarenal Surgery) performed with a flexible ureterorenoscopy is one of the new methods used to treat urinary stones.                                           Intervention group:Under Fluoroscopic Injection:  Fluoroscopic guides are a useful and effective method of determining the correct position of the needle. Fluoroscopy is a simple and accessible tool that can be used in all pain control procedures during surgery.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Kidney stone removal. Timepoint: Once a month. Method of measurement: CT-scan.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Tehran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-09-22</approval_date>
        <contact_name>Ethics Committee for Research in Tehran University of Medical Sciences</contact_name>
        <contact_address>Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
