<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/NCT04435132</url>
  </required_header>
  <id_info>
    <org_study_id>NDR-RA-PA-MY</org_study_id>
    <nct_id>NCT04435132</nct_id>
  </id_info>
  <brief_title>Robotic-assisted Percutaneous Access</brief_title>
  <official_title>Robotic-assisted Percutaneous Access: Interventional, Non-randomized, Open-label, Non-comparative and First-in-Man Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NDR Medical Technology Pte Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Malaya</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NDR Medical Technology Pte Ltd</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>
      This is a first-in-man (FIM) study to show feasibility and safety profile of the newly&#xD;
      developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone&#xD;
      disease who had standard indications for prone PCNL were included in the study. PCNL was&#xD;
      conducted with percutaneous puncture with the aid of robotic device with the use of&#xD;
      intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3&#xD;
      months. Punctures were performed by the board-qualified urologist.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients underwent preoperative investigations and imaging study (CT Urogram/Intravenous&#xD;
      Pyelography) done prior to the operation as per standard operation preparation.&#xD;
      Intraoperatively fluoroscopic imaging was done for the patients and the images were&#xD;
      synchronized to the software. Robotic arm was placed on the site of surgery as for prone PCNL&#xD;
      and diaphragm of the arm was centred over the site of desire calyx of entry. A needle was&#xD;
      engaged into the centre of the diaphragm and using the software the need was aligned in the&#xD;
      line of puncture automatically based on the fluoroscopic images. After the alignment was done&#xD;
      the needle was advanced manually by the surgeon until the entry was confirmed by efflux of&#xD;
      urine from the puncture needle. After the entry was confirmed a standard PCNL using 24 F or&#xD;
      30 F Balloon dilator was performed and stone cleared using Cyberwand/ Shockpulse etc. All the&#xD;
      intraoperative and perioperative parameters as mentioned in the data collection form was&#xD;
      measured. Results was analysed with the main focus on time of obtaining the puncture,&#xD;
      accuracy of puncture, radiation exposure time till calyceal entry which was confirmed by free&#xD;
      flow of urine and for any complications.&#xD;
&#xD;
      Patients aged between 21 to 75 years old who were diagnosed with kidney stone diseas and&#xD;
      planned for prone PCNL with indication for surgery as per standard of care were recruited.&#xD;
      They understood the purpose of testing and offered their voluntary and informed consent.&#xD;
&#xD;
      The robotic device i.e. ANT lesses the learning curve of percutaneous access as it reduces&#xD;
      the need for surgeon's visualization of the calyceal system and the needle alignment. It also&#xD;
      improved efficiency as there is less dependence on human skills during the procedure. As a&#xD;
      whole, the FIM trial was a success. The performance of the ANT system during the trial was&#xD;
      satisfactory. The robot alignment time is less than 30 seconds. Total puncture time was&#xD;
      around 6 minutes and no AEs were reported.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 7, 2018</start_date>
  <completion_date type="Actual">November 1, 2018</completion_date>
  <primary_completion_date type="Actual">November 1, 2018</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>Recruitment was carried out in University Malaya Medical Centre (UMMC) Hospital clinics and impatient wards. 5 patients were recruited with no preferred selection for gender or race. Patients recruited were set to be between 21 to 75 years of age.&#xD;
Patients presenting to to clinic or admitted to ward for renal stone disease were assessed for indications of PCNL. Patients were assessed for renal stone disease as per standard of care - imaging study with CT scan, renal function, clinical assessment of fitness and suitability for prone PCNL.&#xD;
Once patients were planned for prone PCNL, they will be informed about this study, the use of robotic device, potential benefits and complications by study investigators. If they are agreeable to informed consent, they will be recruited into the study.</intervention_model_description>
    <primary_purpose>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device. They will then be admitted to inpatient ward as per standard of care for PCNL.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Needle insertion time</measure>
    <time_frame>During procedure</time_frame>
    <description>Time taken for PCNL procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Needle alignment time</measure>
    <time_frame>During procedure</time_frame>
    <description>Time taken for needle alignment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time to target</measure>
    <time_frame>During procedure</time_frame>
    <description>Time taken for the needle to reach the calyx, from on the skin to successful needle targeting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of needle insertion attempts to obtain access</measure>
    <time_frame>During procedure</time_frame>
    <description>Number of attempts before successfully reaching the calyx</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation dosage from placement of robot to efflux of urine</measure>
    <time_frame>During procedure</time_frame>
    <description>A measure of the radiation exposed during the surgical procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Radiation dosage from placement of robot to successful needle target via image confirmation</measure>
    <time_frame>During procedure</time_frame>
    <description>A measure of the radiation exposed during the surgical procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Kidney Stone</condition>
  <arm_group>
    <arm_group_label>PCNL with the aid of the robotic device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PCL under fluoroscopy with the aid of the robotic device</intervention_name>
    <description>During the surgery, the robot was positioned over the estimated insertion point. It was aligned to be parallel to the fluoroscope imaging plane as much as possible. The needle is to be placed through the holder, and slightly penetrate the surface of the skin. An x-ray image is then taken to ensure that the whole device can be seen on the screen. Image calibration is then performed through the software GUI. After which, the clinician is also to perform needle tip selection. After which, needle alignment will then be performed. Once needle alignment is complete, the clinician will then advance the trocar needle into the patient's body, using the fluoroscopy to judge the penetration depth. Once the target has been reached, the needle style is to be extracted. The indication of leakage of fluid through the outer needle confirms the success of the procedure.</description>
    <arm_group_label>PCNL with the aid of the robotic device</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 21 to 75 years&#xD;
&#xD;
          -  Diagnosed with kidney stone disease and planned for prone PCNL with indication for&#xD;
             surgery as per standard of care&#xD;
&#xD;
          -  Subject who understand the purpose of testing, voluntary and informed consent,&#xD;
             patients undergoing invasive imaging follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Bleeding disorders&#xD;
&#xD;
          -  Patient on anticoagulation/antiplatelets drugs&#xD;
&#xD;
          -  Pyonephrosis&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Not able to have prone position for the procedure due to comorbidities&#xD;
&#xD;
          -  Moderate to severe renal failure&#xD;
&#xD;
          -  The patient's life expectancy is less than 12 months&#xD;
&#xD;
          -  Poor compliance and patients unable to complete the study in accordance with the&#xD;
             requirements.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Malaya Medical Centre</name>
      <address>
        <city>Kuala Lumpur</city>
        <zip>59100</zip>
        <country>Malaysia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <link>
    <url>http://doi.org/10.1097/MOU.0b013e32831cc1ba</url>
    <description>Urologic robots and future directions</description>
  </link>
  <link>
    <url>http://doi.org/10.1016/j.jviscsurg.2011.08.003</url>
    <description>How today's robots work and perspectives for the future. J Visc Surg. 2011</description>
  </link>
  <link>
    <url>http://doi.org/10.1089/end.2018.0003</url>
    <description>Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol 2018 Apr 27</description>
  </link>
  <reference>
    <citation>Mozer P, Troccaz J, Stoianovici D. Urologic robots and future directions. Curr Opin Urol. 2009 Jan;19(1):114-9. doi: 10.1097/MOU.0b013e32831cc1ba.</citation>
    <PMID>19057227</PMID>
  </reference>
  <reference>
    <citation>Cinquin P. How today's robots work and perspectives for the future. J Visc Surg. 2011 Oct;148(5 Suppl):e12-8. doi: 10.1016/j.jviscsurg.2011.08.003. Epub 2011 Oct 5. No abstract available. Erratum In: J Visc Surg. 2012 Feb;149(1):e81.</citation>
    <PMID>21981795</PMID>
  </reference>
  <results_reference>
    <citation>Oo MM, Gandhi HR, Chong KT, Goh JQ, Ng KW, Hein AT, Tan YK. Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol. 2021 Jun;35(6):e919. doi: 10.1089/end.2018.0003.</citation>
    <PMID>29699415</PMID>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 9, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 15, 2020</last_update_submitted>
  <last_update_submitted_qc>June 15, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>PCNL</keyword>
  <keyword>Percutaneous nephrolithotomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Calculi</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/NCT04435132
org study id: NDR-RA-PA-MY
nct id: NCT04435132
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a first-in-man (FIM) study to show feasibility and safety profile of the newly
      developed robotic device for percutaneous access in PCNL surgery. Patients with renal stone
      disease who had standard indications for prone PCNL were included in the study. PCNL was
      conducted with percutaneous puncture with the aid of robotic device with the use of
      intra-operative fluoroscopy. 5 patients were recruited in this pilot study over a period of 3
      months. Punctures were performed by the board-qualified urologist.
All patients underwent preoperative investigations and imaging study (CT Urogram/Intravenous
      Pyelography) done prior to the operation as per standard operation preparation.
      Intraoperatively fluoroscopic imaging was done for the patients and the images were
      synchronized to the software. Robotic arm was placed on the site of surgery as for prone PCNL
      and diaphragm of the arm was centred over the site of desire calyx of entry. A needle was
      engaged into the centre of the diaphragm and using the software the need was aligned in the
      line of puncture automatically based on the fluoroscopic images. After the alignment was done
      the needle was advanced manually by the surgeon until the entry was confirmed by efflux of
      urine from the puncture needle. After the entry was confirmed a standard PCNL using 24 F or
      30 F Balloon dilator was performed and stone cleared using Cyberwand/ Shockpulse etc. All the
      intraoperative and perioperative parameters as mentioned in the data collection form was
      measured. Results was analysed with the main focus on time of obtaining the puncture,
      accuracy of puncture, radiation exposure time till calyceal entry which was confirmed by free
      flow of urine and for any complications.

      Patients aged between 21 to 75 years old who were diagnosed with kidney stone diseas and
      planned for prone PCNL with indication for surgery as per standard of care were recruited.
      They understood the purpose of testing and offered their voluntary and informed consent.

      The robotic device i.e. ANT lesses the learning curve of percutaneous access as it reduces
      the need for surgeon's visualization of the calyceal system and the needle alignment. It also
      improved efficiency as there is less dependence on human skills during the procedure. As a
      whole, the FIM trial was a success. The performance of the ANT system during the trial was
      satisfactory. The robot alignment time is less than 30 seconds. Total puncture time was
      around 6 minutes and no AEs were reported.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Recruitment was carried out in University Malaya Medical Centre (UMMC) Hospital clinics and impatient wards. 5 patients were recruited with no preferred selection for gender or race. Patients recruited were set to be between 21 to 75 years of age.
Patients presenting to to clinic or admitted to ward for renal stone disease were assessed for indications of PCNL. Patients were assessed for renal stone disease as per standard of care - imaging study with CT scan, renal function, clinical assessment of fitness and suitability for prone PCNL.
Once patients were planned for prone PCNL, they will be informed about this study, the use of robotic device, potential benefits and complications by study investigators. If they are agreeable to informed consent, they will be recruited into the study.
primary purpose: Device Feasibility
masking: None (Open Label)
masking description: Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device. They will then be admitted to inpatient ward as per standard of care for PCNL.
measure: Needle insertion time
time frame: During procedure
description: Time taken for PCNL procedure
measure: Needle alignment time
time frame: During procedure
description: Time taken for needle alignment
measure: Time to target
time frame: During procedure
description: Time taken for the needle to reach the calyx, from on the skin to successful needle targeting
measure: Number of needle insertion attempts to obtain access
time frame: During procedure
description: Number of attempts before successfully reaching the calyx
measure: Radiation dosage from placement of robot to efflux of urine
time frame: During procedure
description: A measure of the radiation exposed during the surgical procedure
measure: Radiation dosage from placement of robot to successful needle target via image confirmation
time frame: During procedure
description: A measure of the radiation exposed during the surgical procedure
arm group label: PCNL with the aid of the robotic device
arm group type: Experimental
description: Patients will undergo prone PCNL under fluoroscopic guidance and with the aid of the robotic device.
intervention type: Device
intervention name: PCL under fluoroscopy with the aid of the robotic device
description: During the surgery, the robot was positioned over the estimated insertion point. It was aligned to be parallel to the fluoroscope imaging plane as much as possible. The needle is to be placed through the holder, and slightly penetrate the surface of the skin. An x-ray image is then taken to ensure that the whole device can be seen on the screen. Image calibration is then performed through the software GUI. After which, the clinician is also to perform needle tip selection. After which, needle alignment will then be performed. Once needle alignment is complete, the clinician will then advance the trocar needle into the patient's body, using the fluoroscopy to judge the penetration depth. Once the target has been reached, the needle style is to be extracted. The indication of leakage of fluid through the outer needle confirms the success of the procedure.
arm group label: PCNL with the aid of the robotic device
criteria: 
gender: All
minimum age: 21 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Malaysia
url: http://doi.org/10.1097/MOU.0b013e32831cc1ba
description: Urologic robots and future directions
url: http://doi.org/10.1016/j.jviscsurg.2011.08.003
description: How today's robots work and perspectives for the future. J Visc Surg. 2011
url: http://doi.org/10.1089/end.2018.0003
description: Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol 2018 Apr 27
citation: Mozer P, Troccaz J, Stoianovici D. Urologic robots and future directions. Curr Opin Urol. 2009 Jan;19(1):114-9. doi: 10.1097/MOU.0b013e32831cc1ba.
PMID: 19057227
citation: Cinquin P. How today's robots work and perspectives for the future. J Visc Surg. 2011 Oct;148(5 Suppl):e12-8. doi: 10.1016/j.jviscsurg.2011.08.003. Epub 2011 Oct 5. No abstract available. Erratum In: J Visc Surg. 2012 Feb;149(1):e81.
PMID: 21981795
citation: Oo MM, Gandhi HR, Chong KT, Goh JQ, Ng KW, Hein AT, Tan YK. Automated Needle Targeting with X-ray (ANT-X) - Robot-assisted device for percutaneous nephrolithotomy (PCNL) with its first successful use in human. J Endourol. 2021 Jun;35(6):e919. doi: 10.1089/end.2018.0003.
PMID: 29699415
responsible party type: Sponsor
mesh term: Kidney Calculi
sharing ipd: No