<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/NCT04504019</url>
  </required_header>
  <id_info>
    <org_study_id>WRNMMC-2020-0278</org_study_id>
    <nct_id>NCT04504019</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of USCTR vs. mOCTR</brief_title>
  <official_title>Clinical Outcomes of Carpal Tunnel Release With and Without Ultrasound Guidance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Walter Reed National Military Medical Center</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Uniformed Services University of the Health Sciences</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>Walter Reed National Military Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects&#xD;
      3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal&#xD;
      tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are&#xD;
      performed annually in the United States with over 90% of patients reporting clinical&#xD;
      improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm&#xD;
      palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm&#xD;
      incisions (ECTR), and ultrasound guided CTR via a single &lt; 1 cm wrist or palmar incision&#xD;
      (USCTR). The primary objective is to assess the impact of USCTR vs mOCTR in a military&#xD;
      population. This study is a multi-site prospective randomized comparative trial.&#xD;
&#xD;
      Participants with CTS will be randomized to a study arm and receive treatment with ultrasound&#xD;
      guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (mOCTR).&#xD;
      All patients will be followed for a period of 24 months with respect to standard clinical&#xD;
      data, military relevant data, and validated patient related outcome measures (PROMs). Data&#xD;
      will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12&#xD;
      months, and 24 months post-CTR procedure.&#xD;
&#xD;
      Investigators hypothesize that USCTR using the SX-One MicroKnife® will safely and&#xD;
      more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR,&#xD;
      with less loss of military duty days.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 11, 2020</start_date>
  <completion_date type="Anticipated">August 2023</completion_date>
  <primary_completion_date type="Anticipated">July 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.</measure>
    <time_frame>Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-S.</measure>
    <time_frame>Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the effect of USCTR vs mOCTR on the longitudinal change in hand pinch and grip strength.</measure>
    <time_frame>Change from baseline to 3 months, and 12 months post CTR procedure</time_frame>
    <description>Manually tested using a dynamometer.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition</measure>
    <time_frame>Change from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in military work status as assessed using single-item self-report assessment</measure>
    <time_frame>Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>Participants will complete a questionnaire to depict when normal work or daily activities commenced.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical time during procedure (minutes)</measure>
    <time_frame>At time of procedure, measured as day 0</time_frame>
    <description>On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported satisfaction as assessed using a satisfaction rating scale</measure>
    <time_frame>Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.&#xD;
Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure.</measure>
    <time_frame>Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure</time_frame>
    <description>The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in pain medication usage as assessed using single-item self-report assessment</measure>
    <time_frame>Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure</time_frame>
    <description>Participant self-reported pain medication usage. Participant will respond with responses ranging from &quot;less than once a week', &quot;once a week&quot;, &quot;several times a week&quot;, &quot;daily&quot;, &quot;multiple times per day&quot;, &quot;or did not use&quot;. &quot;Did not use&quot; will represent the minimum value, and &quot;multiple times per day&quot; will represent the maximum value.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incision length in cm</measure>
    <time_frame>At time of procedure, measured as day 0</time_frame>
    <description>On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS)</measure>
    <time_frame>At time of procedure, measured as day 0</time_frame>
    <description>Using the 11-item Pain Numeric Rating Scale (NRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.&#xD;
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in self-reported pain as assessed using the 4-item CTS Palmar Pain Scale over 1 month following CTR procedure</measure>
    <time_frame>Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure</time_frame>
    <description>The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">510</enrollment>
  <condition>Carpal Tunnel</condition>
  <arm_group>
    <arm_group_label>USCTR Procedure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will undergo the USCTR procedure with SX-One MicroKnife®</description>
  </arm_group>
  <arm_group>
    <arm_group_label>mOCTR Procedure</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Participants will undergo the traditional mOCTR procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>USCTR</intervention_name>
    <description>Ultrasound guided CTR via a single &lt; 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®</description>
    <arm_group_label>USCTR Procedure</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mOCTR</intervention_name>
    <description>Mini-open CTR via a single 1-3cm palmar incision</description>
    <arm_group_label>mOCTR Procedure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults age ≥18 years&#xD;
&#xD;
          -  DEERS Eligible&#xD;
&#xD;
          -  Fluent in speaking, reading, and understanding English&#xD;
&#xD;
          -  Clinical diagnosis of Carpal Tunnel Syndrome (CTS)&#xD;
&#xD;
          -  Candidate for surgical CTR based on severe and/or refractory symptoms&#xD;
&#xD;
          -  Confirmatory electrodiagnostic test indicating median neuropathy at the wrist&#xD;
             (abnormal findings)&#xD;
&#xD;
          -  Ultrasound findings consistent with median nerve enlargement in the carpal tunnel&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous carpal tunnel release or previous wrist surgery on the ipsilateral side&#xD;
&#xD;
          -  Carpal tunnel injection with corticosteroid within 6 weeks prior to anticipated study&#xD;
             procedure&#xD;
&#xD;
          -  Previous traumatic injury to the median nerve or any of its branches on the&#xD;
             ipsilateral side&#xD;
&#xD;
          -  History of medical condition that would preclude safe participation in study&#xD;
             procedures (e. g. complex regional pain syndrome (CRPS), upper limb vascular disease&#xD;
             (including thoracic outlet syndrome), Raynaud's phenomenon, etc.)&#xD;
&#xD;
          -  Inability to stop anticoagulation medications (Plavix, Coumadin/Warfarin, Xarelto), or&#xD;
             unable to be bridged with Lovenox&#xD;
&#xD;
          -  Unable to understand and provide written informed consent&#xD;
&#xD;
          -  Contraindication to proceeding with USCTR based on diagnostic ultrasound (i.e.&#xD;
             identification of anomalous anatomic structures such as bifid median nerve or space&#xD;
             occupying lesions within the carpal tunnel)&#xD;
&#xD;
          -  Electrodiagnostic evaluation of the carpal tunnel which indicates normal findings&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Miller, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Walter Reed National Military Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Matthew Miller, MD</last_name>
    <phone>301-295-7752</phone>
    <email>matthew.e.miller78.mil@mail.mil</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Whitley Lucio</last_name>
    <email>whitley.lucio.ctr@usuhs.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Walter Reed National Military Medical Center</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Matthew Miller</last_name>
      <email>matthew.e.miller78.mil@mail.mil</email>
    </contact>
    <investigator>
      <last_name>Matthew Miller, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>May 18, 2021</last_update_submitted>
  <last_update_submitted_qc>May 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Median Nerve Neuropathy Treatments</keyword>
  <keyword>Ultrasound Guided Carpal Tunnel Release (USCTR)</keyword>
  <keyword>Military</keyword>
  <keyword>Minimally Invasive Carpal Tunnel Release</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carpal Tunnel Syndrome</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/NCT04504019
org study id: WRNMMC-2020-0278
nct id: NCT04504019
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy and affects
      3-6% of adults in the United States. In patients with severe or refractory symptoms, carpal
      tunnel release (CTR) represents the definitive management option, and over 550,000 CTRs are
      performed annually in the United States with over 90% of patients reporting clinical
      improvement. Currently available CTR techniques include mini-open CTR via a single, 1-3 cm
      palmar incision (mOCTR), endoscopic CTR via one (wrist) or two (wrist and palm) 1-2 cm
      incisions (ECTR), and ultrasound guided CTR via a single < 1 cm wrist or palmar incision
      (USCTR). The primary objective is to assess the impact of USCTR vs mOCTR in a military
      population. This study is a multi-site prospective randomized comparative trial.

      Participants with CTS will be randomized to a study arm and receive treatment with ultrasound
      guided carpal tunnel release (USCTR) vs. traditional mini-open carpal tunnel release (mOCTR).
      All patients will be followed for a period of 24 months with respect to standard clinical
      data, military relevant data, and validated patient related outcome measures (PROMs). Data
      will be collected at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, and 12
      months, and 24 months post-CTR procedure.

      Investigators hypothesize that USCTR using the SX-One MicroKnife® will safely and
      more-effectively improve symptoms of carpal tunnel syndrome compared to traditional mOCTR,
      with less loss of military duty days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measure the effect of USCTR vs mOCTR on the longitudinal change in QuickDASH.
time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: QuickDash is a region-specific PROM consisting of 11 items measuring the difficulty in performing physical activities relevant to shoulder, arm or hand function. Each item is scored on a scale of 1-5 and a final score of 0 to 100 is calculated, with higher scores representing greater degrees of upper extremity disability (0 points indicate no disability and 100 points indicates maximum disability).
measure: Measure the effect of USCTR vs mOCTR on the longitudinal change in BCTQ-S.
time frame: Change from baseline to 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: The BCTQ is a PROM for CTS and is the most commonly used outcome measure for CTS. Each item on the 11-item symptom severity scale (BCTQ-S) is graded from 1 (mildest) to 5 (most severe). Outcomes are typically recorded as a mean score.
measure: Measure the effect of USCTR vs mOCTR on the longitudinal change in hand pinch and grip strength.
time frame: Change from baseline to 3 months, and 12 months post CTR procedure
description: Manually tested using a dynamometer.
measure: Measure the impact of USCTR vs mOCTR on participant perception of change in overall physical condition
time frame: Change from 1 week to 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: Participant self reported change in physical condition. Participant will select one response from the following descriptions to rate overall condition from the time they began treatment to the designated time-point: A very great deal worse; About the same; A very great deal better; A great deal worse; A great deal better; Quite a bit worse; Quite a bit better; Moderately worse; Moderately better; Somewhat worse; Somewhat better; A little bit worse; A little bit better; A tiny bit worse(almost the same); A tiny bit better (almost the same)
measure: Change in military work status as assessed using single-item self-report assessment
time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: Participants will complete a questionnaire to depict when normal work or daily activities commenced.
measure: Surgical time during procedure (minutes)
time frame: At time of procedure, measured as day 0
description: On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record surgical time to perform the procedure in minutes
measure: Change in self-reported satisfaction as assessed using a satisfaction rating scale
time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: Participants will rate satisfaction with the following: completely dissatisfied, mostly dissatisfied, somewhat satisfied, neither satisfied or dissatisfied, somewhat satisfied, mostly satisfied, or completely satisfied.
Completely dissatisfied with represent the lowest score, and completely satisfied will represent the highest score.
measure: Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS) participant pain levels over 1 month following the CTR procedure.
time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
description: The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
measure: Change in pain medication usage as assessed using single-item self-report assessment
time frame: Captured at 1 week, 2 weeks, 3 weeks, 1 month, 6 weeks, 3 months, 6 months, 12 months, and 24 months post CTR procedure
description: Participant self-reported pain medication usage. Participant will respond with responses ranging from "less than once a week', "once a week", "several times a week", "daily", "multiple times per day", "or did not use". "Did not use" will represent the minimum value, and "multiple times per day" will represent the maximum value.
measure: Incision length in cm
time frame: At time of procedure, measured as day 0
description: On the day the participant receives their study assigned procedure (USCTR vs. mOCTR), clinical team will record incision length in cm
measure: Change in self-reported pain as assessed using the 11-item Pain Numeric Rating Scale (NRS)
time frame: At time of procedure, measured as day 0
description: Using the 11-item Pain Numeric Rating Scale (NRS), compare the distributions of participant self-reported pain at both pre- and immediately -post CTR procedure between the USCTR and mOCTR groups.
The 11-item NRS scale is a unidimensional measure of pain intensity. It is a segmented numeric version of the visual analog scale in which participants will select a whole number (0-10 integers) that best reflects the intensity of their pain. The scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. worst possible pain).
measure: Change in self-reported pain as assessed using the 4-item CTS Palmar Pain Scale over 1 month following CTR procedure
time frame: Captured at 1 week, 2 weeks, 3 weeks, and 1 month post CTR procedure
description: The 4-item Carpal Tunnel Syndrome Palmer and Incision Pain questionnaire inquiries about severity of pain. Each item has five-six possible response options which range from 1 (no pain) to 5/6 (very severe). The symptom score is the mean of all answered items; higher scores indicate worse symptoms
arm group label: USCTR Procedure
arm group type: Experimental
description: Participants will undergo the USCTR procedure with SX-One MicroKnife®
arm group label: mOCTR Procedure
arm group type: Active Comparator
description: Participants will undergo the traditional mOCTR procedure.
intervention type: Device
intervention name: USCTR
description: Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®
arm group label: USCTR Procedure
intervention type: Procedure
intervention name: mOCTR
description: Mini-open CTR via a single 1-3cm palmar incision
arm group label: mOCTR Procedure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Matthew Miller, MD
role: Principal Investigator
affiliation: Walter Reed National Military Medical Center
last name: Matthew Miller, MD
phone: 301-295-7752
email: matthew.e.miller78.mil@mail.mil
last name: Whitley Lucio
email: whitley.lucio.ctr@usuhs.edu
facility: 
status: Recruiting
contact: 
investigator: 
country: United States
responsible party type: Sponsor
mesh term: Carpal Tunnel Syndrome
sharing ipd: No