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/NCT06013514</url>
    </required_header>
    <id_info>
      <org_study_id>DM6 640 0101</org_study_id>
      <nct_id>NCT06013514</nct_id>
    </id_info>
    <brief_title>Post-market Prospective Clinical Study of Nagor Perle Mammary Implants</brief_title>
    <acronym>PERLE10PMCF</acronym>
    <official_title>A Prospective, Multi-center, Observational, Non Comparative, Post-marketing Surveillance Study to Obtain Clinical Outcome Data on the Nagor PERLE Range of Silicone Breast Implants When Used in Breast Implantation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GC Aesthetics</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GC Aesthetics</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>
        Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive&#xD;
        being the primary indications. In order to confidently state safety and due to strict&#xD;
        regulation on medical devices it is important to maintain a record of safety and performance&#xD;
        with all medical implants.&#xD;
  &#xD;
        This study is designed to collect data on a new generation of smooth mammary implants to&#xD;
        assess the long term performance and safety data on this type of gel-filled mammary breast&#xD;
        implant.&#xD;
  &#xD;
        The two main complications of breast implants are capsular contracture and rupture; these&#xD;
        complications can take years to develop. The study is designed to evaluate the occurrence of&#xD;
        these two primary complication as well as other secondary complications over a period of 10&#xD;
        years. Patient follow up will be carried out pre-operatively and post operatively at 12&#xD;
        months and then 3, 5, 8 and 10 years thereafter.&#xD;
  &#xD;
        The study will be carried out over 10 years to adequately assess complications which may only&#xD;
        occur over the lifetime of the device such as systemic complications&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2035</completion_date>
    <primary_completion_date type="Anticipated">September 2035</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Rate of capsular contracture (Baker grade III-IV)</measure>
      <time_frame>10 years post-surgery</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of implant rupture</measure>
      <time_frame>10 years post-surgery</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rate of the secondary surgical procedures required for correction of complications</measure>
      <time_frame>10 years post-surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants</measure>
      <time_frame>10 years post-surgery</time_frame>
      <description>Capsular contracture of Baker Grade I-II&#xD;
  Haematoma&#xD;
  Rupture&#xD;
  Seroma&#xD;
  Severe and continuing pain&#xD;
  Post-operative infection&#xD;
  Explantation as a result of infection&#xD;
  Implant displacement/extrusion&#xD;
  Wrinkling/folds&#xD;
  Breast Implant Associate Anaplastic Large Cell Lymphoma&#xD;
  BII/Asia&#xD;
  Delayed or abnormal wound healing occurring within the first 3 months of surgery&#xD;
  Any other complications considered by the Investigator to be related to the device or surgical procedure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction</measure>
      <time_frame>10 years post-surgery</time_frame>
      <description>BREAST- Q method</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>rate and frequency of any adverse events</measure>
      <time_frame>10 years post-surgery</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">700</enrollment>
    <condition>Breast Reconstruction</condition>
    <condition>Breast Reconstruction Following Mastectomy</condition>
    <condition>Breast Revision</condition>
    <condition>Breast Augmentation</condition>
    <condition>Breast Reconstruction With Silicone Implants</condition>
    <condition>Breast Reconstruction After Mastectomy</condition>
    <condition>Breast Reconstruction Surgery</condition>
    <condition>Breast Implants</condition>
    <arm_group>
      <arm_group_label>Smooth Silicone Breast Implant</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>PERLE Sterile Smooth Opaque gel filled mammary implants</intervention_name>
      <description>Sterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs</description>
      <arm_group_label>Smooth Silicone Breast Implant</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Female 18-65 requiring breast surgery for iether augmentation, reconstruction or revision,&#xD;
          meeting inclusion and non inclusion criteria&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Genetic female subjects aged ≥18 and ≤65&#xD;
  &#xD;
            2. Subjects who underwent single or bilateral breast implantation with the study device&#xD;
               for one of the following reasons:-&#xD;
  &#xD;
          i) Primary breast reconstruction following mastectomy (both for one-stage or two-stage&#xD;
          surgeries, including patients with previous radiotherapy and who have ADMs of animal origin&#xD;
          (bovine, porcine)). ii) Primary breast augmentation (cosmetic surgery) with or without&#xD;
          mastopexy iii) Breast revision surgery with or without mastopexy c) Subjects who have&#xD;
          received a Nagor PERLE implant. d) Subjects who have provided informed consent and can&#xD;
          adhere to the requirements of follow up appointments as per the study protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Subjects undergoing implant augmentation with a BMI &gt; 30 and undergoing reconstruction&#xD;
               with a BMI &gt;32.&#xD;
  &#xD;
            2. Subjects with autoimmune disease, lung fibrocystic disease, conditions that interfere&#xD;
               with wound healing and blood clotting, a weakened immune system, reduced blood supply&#xD;
               to the breast tissue or any other condition for which breast implants are&#xD;
               contraindicated.&#xD;
  &#xD;
            3. Subjects who have participated in a clinical study which involve chemical or drug&#xD;
               study within 3 months prior to surgery, with the exception of subjects who are&#xD;
               participating in breast cancer related clinical studies.&#xD;
  &#xD;
            4. Subjects with insufficient tissue covering due to either radiation damage on the chest&#xD;
               wall, tight thoracic skin grafts or radical resection of the pectoralis major muscle.&#xD;
  &#xD;
            5. Subjects who have ADMs of synthetic origin.&#xD;
  &#xD;
            6. Subjects who, in the Investigator's clinical opinion, have existing local or&#xD;
               metastatic carcinoma of the breast that is unlikely to be fully excised at the time of&#xD;
               insertion of the breast implant.&#xD;
  &#xD;
            7. Subjects with known previous history of a sensitivity to silicone who, in the opinion&#xD;
               of the Investigator, are unsuitable for surgery.&#xD;
  &#xD;
            8. Subjects with an active infection who are unsuitable for surgery unless, in the&#xD;
               opinion of the investigator, they are treated and cleared by the investigator.&#xD;
  &#xD;
            9. Subjects with a history of abscesses anywhere in the body who, in the opinion of the&#xD;
               Investigator, are unsuitable for surgery.&#xD;
  &#xD;
           10. Subjects with a known history of compromised wound healing.&#xD;
  &#xD;
           11. Subjects who, in the opinion of the Investigator, have an existing condition that&#xD;
               would compromise their participation and follow-up in this study.&#xD;
  &#xD;
           12. Women who are pregnant and/or current breast feeders who do not stop breast feeding&#xD;
               within 3 months of getting breast implants&#xD;
  &#xD;
           13. Patients who have local recurrence or metastatic carcinoma at the time of insertion of&#xD;
               breast implant&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>prospective</keyword>
    <keyword>observational</keyword>
    <keyword>non-comparative</keyword>
    <keyword>post-marketing study</keyword>
    <keyword>PMCF</keyword>
    <keyword>Perle</keyword>
    <keyword>Nagor</keyword>
    <keyword>GCA</keyword>
    <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/NCT06013514
  org study id: DM6 640 0101
  nct id: NCT06013514
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Patients can undergo breast implant surgery for multiple reasons; cosmetic and reconstructive
        being the primary indications. In order to confidently state safety and due to strict
        regulation on medical devices it is important to maintain a record of safety and performance
        with all medical implants.
  
        This study is designed to collect data on a new generation of smooth mammary implants to
        assess the long term performance and safety data on this type of gel-filled mammary breast
        implant.
  
        The two main complications of breast implants are capsular contracture and rupture; these
        complications can take years to develop. The study is designed to evaluate the occurrence of
        these two primary complication as well as other secondary complications over a period of 10
        years. Patient follow up will be carried out pre-operatively and post operatively at 12
        months and then 3, 5, 8 and 10 years thereafter.
  
        The study will be carried out over 10 years to adequately assess complications which may only
        occur over the lifetime of the device such as systemic complications
  observational model: Cohort
  time perspective: Prospective
  measure: Rate of capsular contracture (Baker grade III-IV)
  time frame: 10 years post-surgery
  measure: Rate of implant rupture
  time frame: 10 years post-surgery
  measure: Rate of the secondary surgical procedures required for correction of complications
  time frame: 10 years post-surgery
  measure: Rate and frequency of local complications associated with the use of Nagor gel-filled mammary implants
  time frame: 10 years post-surgery
  description: Capsular contracture of Baker Grade I-II
  Haematoma
  Rupture
  Seroma
  Severe and continuing pain
  Post-operative infection
  Explantation as a result of infection
  Implant displacement/extrusion
  Wrinkling/folds
  Breast Implant Associate Anaplastic Large Cell Lymphoma
  BII/Asia
  Delayed or abnormal wound healing occurring within the first 3 months of surgery
  Any other complications considered by the Investigator to be related to the device or surgical procedure
  measure: Patient satisfaction
  time frame: 10 years post-surgery
  description: BREAST- Q method
  measure: rate and frequency of any adverse events
  time frame: 10 years post-surgery
  arm group label: Smooth Silicone Breast Implant
  intervention type: Device
  intervention name: PERLE Sterile Smooth Opaque gel filled mammary implants
  description: Sterile smooth opaque gel filled mammary implants will be implanted in adult women having breast surgery for either augmentation, reconstruction or revision surgery. Different ranges of implants will be used to suit patient needs
  arm group label: Smooth Silicone Breast Implant
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  gender based: Yes
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  responsible party type: Sponsor
  sharing ipd: No