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/NCT06041321</url>
    </required_header>
    <id_info>
      <org_study_id>21-0250</org_study_id>
      <nct_id>NCT06041321</nct_id>
    </id_info>
    <brief_title>Novel Bioactive Sleeve on Pain and PROMs</brief_title>
    <official_title>THE EFFECT OF A NOVEL BIOACTIVE SLEEVE ON POSTOPERATIVE PAIN AND PATIENT REPORTED OUTCOME SCORES AFTER ARTHROSCOPIC MENISCECTOMY AND MENISCUS REPAIRS: A RANDOMIZED PLACEBO CONTROLLED STUDY</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Northwell Health</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Reparel</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Northwell Health</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to&#xD;
        assess pain outcomes, patient reported outcome measures, and effectiveness of healing based&#xD;
        on range of motion.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a blinded randomized prospective study comparing two postoperative leg sleeves. The&#xD;
        novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a&#xD;
        similar feel/compression. The main hypothesis for this study is that postoperative use of a&#xD;
        novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease&#xD;
        pain and improve patient reported outcome scores faster and more reliably than the control&#xD;
        non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled&#xD;
        for meniscectomy/meniscus repair will be randomized to one of the two arms in order to&#xD;
        minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS&#xD;
        JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill&#xD;
        out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week,&#xD;
        3-month, 6-month, 1 year, and 2-year mark.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2024</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>
      <intervention_model_description>This is a phase IV, parallel designed, placebo controlled, randomized clinical trial</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Investigator)</masking>
      <masking_description>The Biostatistics Unit will develop and implement the randomization procedure using the Biostatistics Randomization Management System (BRMS). The Biostatistics Randomization Management System (BRMS) is a secure, HIPAA-compliant, web-based application that allows investigators to randomize subjects into randomized clinical trials (RCTs) using their personal computer. The BRMS allows for multi-center, stratified, and single/double blinded RCTs, using permuted blocks. Randomization notifications (respectful of blinding status) are automatically sent to the PI and other authorized personnel. BRMS includes a feature that allows for medically indicated breaking of the blind, with requirement for justification. BRMS includes an audit trail of all transactions.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>VAS Pain Score</measure>
      <time_frame>2 years</time_frame>
      <description>Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Range of Motion</measure>
      <time_frame>2 years</time_frame>
      <description>Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to range of motion testing</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Meniscus Tear</condition>
    <arm_group>
      <arm_group_label>Reparel Sleeve</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down.&#xD;
  501k exempt: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking/Medical Support</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo Sleeve</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Reparel Sleeve</intervention_name>
      <description>For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.</description>
      <arm_group_label>Reparel Sleeve</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Placebo Sleeve</intervention_name>
      <description>Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.</description>
      <arm_group_label>Placebo Sleeve</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Provision of signed and dated informed consent form&#xD;
  &#xD;
            -  Stated willingness to comply with all study procedures and availability for the&#xD;
               duration of the study&#xD;
  &#xD;
            -  Male or female, over the age of 18, undergoing a meniscectomy or meniscus repair&#xD;
  &#xD;
            -  In good general health as evidenced by medical history&#xD;
  &#xD;
            -  Under 45th percentile BMI&#xD;
  &#xD;
            -  Willing to adhere to the study intervention regimenregimen.&#xD;
  &#xD;
            -  Kellgren-Lawrence grade 2 or less&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Febrile illness within 3 months&#xD;
  &#xD;
            -  BMI over 40&#xD;
  &#xD;
            -  Treatment with another investigational drug or other intervention within 6 months&#xD;
  &#xD;
            -  Kellgren-Lawrence grade 3 or more or 4&#xD;
  &#xD;
            -  History of autoimmune disease, circulatory disease, or vascular disorder&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>89 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Nadia Baichoo, MA</last_name>
      <phone>516-640-1765</phone>
      <email>nbaichoo@orlincohen.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Summer Koepplin</last_name>
      <phone>516-427-0340</phone>
      <email>skoepplin@orlincohen.com</email>
    </overall_contact_backup>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 11, 2023</study_first_submitted>
    <study_first_submitted_qc>September 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 11, 2023</last_update_submitted>
    <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Northwell Health</investigator_affiliation>
      <investigator_full_name>James Paci</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT06041321
  org study id: 21-0250
  nct id: NCT06041321
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  A novel bioactive sleeve will be compared to a placebo sleeve with a similar look and feel to
        assess pain outcomes, patient reported outcome measures, and effectiveness of healing based
        on range of motion.
  This is a blinded randomized prospective study comparing two postoperative leg sleeves. The
        novel bioactive sleeve (Reparel Leg Sleeve) will be compared to a regular black sleeve with a
        similar feel/compression. The main hypothesis for this study is that postoperative use of a
        novel bioactive sleeve after partial arthroscopic meniscectomy/meniscus repair will decrease
        pain and improve patient reported outcome scores faster and more reliably than the control
        non-bioactive sleeve. In order to test this hypothesis, approximately 100 patients scheduled
        for meniscectomy/meniscus repair will be randomized to one of the two arms in order to
        minimize bias. The following variables will be assessed: patient reported outcomes (VAS, KOOS
        JR, VR12, and KSS Satisfaction), physical therapy time, motor testing. Each patient will fill
        out a series of PROMs preoperatively, and post operatively at the 1-week, 2-week, 6-week,
        3-month, 6-month, 1 year, and 2-year mark.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: This is a phase IV, parallel designed, placebo controlled, randomized clinical trial
  primary purpose: Basic Science
  masking: Double (Participant, Investigator)
  masking description: The Biostatistics Unit will develop and implement the randomization procedure using the Biostatistics Randomization Management System (BRMS). The Biostatistics Randomization Management System (BRMS) is a secure, HIPAA-compliant, web-based application that allows investigators to randomize subjects into randomized clinical trials (RCTs) using their personal computer. The BRMS allows for multi-center, stratified, and single/double blinded RCTs, using permuted blocks. Randomization notifications (respectful of blinding status) are automatically sent to the PI and other authorized personnel. BRMS includes a feature that allows for medically indicated breaking of the blind, with requirement for justification. BRMS includes an audit trail of all transactions.
  measure: VAS Pain Score
  time frame: 2 years
  description: Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to pain.
  measure: Range of Motion
  time frame: 2 years
  description: Assessing the effectiveness of a bioactive sleeve against a non-bioactive sleeve with regard to range of motion testing
  arm group label: Reparel Sleeve
  arm group type: Experimental
  description: Device size(s): Small, medium, large, x-large Device model(s): Reparel Leg Sleeve (full length) Description of each component: Fabric garment constructed of 41% Polyester embedded with a proprietary non-metal semiconductive nano-sized material, 13% Polyester, 27% Nylon, and 19% Lycra-Spandex. The top cuff of the garment has silicone grips to keep the garment from sliding down.
  501k exempt: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?ID=FQL Company Name: Challenger Health, LLC (dba Reparel) FDA Registration Number: 3012651665 Device Listing Number: D269770 Product Classification: Class I Medical Device, 510(k) exempt Product Code: FQL, Stocking/Medical Support
  arm group label: Placebo Sleeve
  arm group type: Placebo Comparator
  description: Device size(s): Small, medium, large, x-large Device model(s): Generic Black Leg Sleeve Supplier: Jupin Group Co., Ltd. Description of each component: Fabric garment constructed of 80% polyester and 20% lycra
  intervention type: Device
  intervention name: Reparel Sleeve
  description: For the purpose of this study, the Reparel Sleeve will be evaluated against a placebo sleeve of similar feel, texture, and look. The indication is that due to its technology, the Reparel sleeve will allow for the ability to reflect energy using a blend of semi-conductors grounded to nanoparticles interwoven between fibers of the sleeve. Thermal energy is then absorbed from the patient thus activating electrons on the nanoparticles and releasing photonic energy directed at tissues within the surrounding area7. This photostimulation is expected to alleviate pain and inflammation while promoting wound healing as well as tissue regeneration.
  arm group label: Reparel Sleeve
  intervention type: Device
  intervention name: Placebo Sleeve
  description: Generic sleeve used as a placebo. This placebo will have a similar feel, texture, and look with no additional technology.
  arm group label: Placebo Sleeve
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 89 Years
  healthy volunteers: No
  last name: Nadia Baichoo, MA
  phone: 516-640-1765
  email: nbaichoo@orlincohen.com
  last name: Summer Koepplin
  phone: 516-427-0340
  email: skoepplin@orlincohen.com
  responsible party type: Principal Investigator
  investigator affiliation: Northwell Health
  investigator full name: James Paci
  investigator title: MD
  sharing ipd: No