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/NCT05975372</url>
    </required_header>
    <id_info>
      <org_study_id>67363</org_study_id>
      <nct_id>NCT05975372</nct_id>
    </id_info>
    <brief_title>Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction</brief_title>
    <official_title>Blossom® Smart Expander Device for Tissue Expander/Implant-Based Breast Reconstruction</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Stanford University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Marz Medical, Inc.</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The conventional breast tissue expander used for breast reconstruction/ augmentation requires&#xD;
        weekly or biweekly injections of saline through the skin and into an integrated port in the&#xD;
        implant using a needle and syringe in order to expand breast skin, which is an in-office&#xD;
        procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently&#xD;
        available on the market, aims to achieve the same tissue expansion while avoiding frequent&#xD;
        injections through the skin by means of an expansion device that slowly and continuously&#xD;
        injects a very small amount of saline. Expansion of the device is based on pressure and&#xD;
        volume in the expander, allowing for a tailored expansion process for individual patients'&#xD;
        physiology. The purpose of this study is to assess the clinical effectiveness of Blossom&#xD;
        Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/&#xD;
        augmentation compared to standard tissue expansion methods.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and&#xD;
        opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will&#xD;
        be given the option of study enrollment. Consenting patients will be enrolled and randomized&#xD;
        1:1 to undergo standard 2-staged breast reconstruction/ augmentation with conventional tissue&#xD;
        expansion (control) or with application Blossom Smart Expander Technology (intervention) in&#xD;
        the first stage reconstruction (tissue expansion).&#xD;
  &#xD;
        The intervention group involves the placement of the Mentor Spectrum tissue expander coupled&#xD;
        with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to&#xD;
        exchange the device to a permanent implant is normal part of standard care.&#xD;
  &#xD;
        A Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom&#xD;
        Syringe Assist device, will be inserted above the pectoralis major muscle in the usual&#xD;
        fashion. The nature of the surgery remains identical to that employed for conventional breast&#xD;
        tissue expander insertion for reconstruction or augmentation.&#xD;
  &#xD;
        Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with&#xD;
        documentation of clinical data throughout will also take place until completion of the&#xD;
        expansion, stabilization of surgical scars, and removal of all percutaneous drains.&#xD;
        Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical&#xD;
        practice in implant-based breast reconstruction in preparation for the second stage expander&#xD;
        to definitive implant exchange.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">September 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>Participants will be randomized to either undergo tissue expansion with the Blossom device (intervention group) or standard tissue expansion methods (control group).</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>By nature of the visible device, participants and care providers cannot be blinded to the treatments. Analysis of data generated during the trial will be blinded to the treatment groups.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Time until completion of tissue expansion</measure>
      <time_frame>Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.</time_frame>
      <description>The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Incidence of complications</measure>
      <time_frame>Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)</time_frame>
      <description>Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and/ or device malfunction, etc. will be monitored and recorded in each study arm.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction (BreastQ)</measure>
      <time_frame>Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).</time_frame>
      <description>Patient satisfaction will be assessed using the validated BreastQ survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient satisfaction (device specific survey)</measure>
      <time_frame>Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).</time_frame>
      <description>Patient satisfaction will be assessed using a device-specific survey.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pain associated with tissue expansion</measure>
      <time_frame>Patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).</time_frame>
      <description>Pain will be assessed using a study-specific survey.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Tissue Expansion</condition>
    <condition>Implant Based Breast Reconstruction</condition>
    <arm_group>
      <arm_group_label>Blossom tissue expander</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation.&#xD;
  Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be automatic via the Blossom device until appropriate volume is achieved. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard tissue expansion</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The standard tissue expansion group will undergo the same procedure with placement of the Mentor Spectrum tissue expander inserted above the pectoralis major muscle in the usual fashion. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be achieved via serial injections of sterile saline into the tissue expander during postoperative follow up visits. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Blossom tissue expander</intervention_name>
      <description>Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.</description>
      <arm_group_label>Blossom tissue expander</arm_group_label>
      <other_name>Blossom smart expander device</other_name>
      <other_name>Marz blossom syringe assist device</other_name>
      <other_name>Blossom syringe assist device</other_name>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Standard tissue expansion</intervention_name>
      <description>Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.</description>
      <arm_group_label>Standard tissue expansion</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women ages 18 or older; pursuing non-oncologic breast reconstruction or augmentation;&#xD;
               and ability to understand and the willingness to sign a written informed consent&#xD;
               document (english language). Only patients desiring 2-staged tissue expander/&#xD;
               implant-based breast reconstruction will be approached for potential enrollment in the&#xD;
               study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with active breast cancer; recent steroid use; major medical comorbidities&#xD;
               (defined as ASA III or greater); a connective tissue disorder; are pregnant or&#xD;
               nursing; are unable to understand and sign the english language consent forms; or age&#xD;
               over 65 years, will be excluded from the study.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Dung H Nguyen, MD, PharmD</last_name>
      <phone>(650) 725-2766</phone>
      <email>nguyendh@stanford.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shannon Meyer, CCRC</last_name>
      <phone>510-418-3831</phone>
      <email>smeyer27@stanford.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Stanford Hospital and Clinics</name>
        <address>
          <city>Palo Alto</city>
          <state>California</state>
          <zip>94304</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 5, 2023</last_update_submitted>
    <last_update_submitted_qc>August 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Dung Nguyen</investigator_full_name>
      <investigator_title>Clinical Professor</investigator_title>
    </responsible_party>
    <keyword>Implant based breast reconstruction</keyword>
    <keyword>Tissue expansion</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/NCT05975372
  org study id: 67363
  nct id: NCT05975372
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The conventional breast tissue expander used for breast reconstruction/ augmentation requires
        weekly or biweekly injections of saline through the skin and into an integrated port in the
        implant using a needle and syringe in order to expand breast skin, which is an in-office
        procedure and can be uncomfortable for patients. Blossom Smart Expander Technology, currently
        available on the market, aims to achieve the same tissue expansion while avoiding frequent
        injections through the skin by means of an expansion device that slowly and continuously
        injects a very small amount of saline. Expansion of the device is based on pressure and
        volume in the expander, allowing for a tailored expansion process for individual patients'
        physiology. The purpose of this study is to assess the clinical effectiveness of Blossom
        Smart Expander Technology in 2-staged tissue expander/implant-based breast reconstruction/
        augmentation compared to standard tissue expansion methods.
  All consenting patients presenting to Dr. Dung Nguyen's breast reconstruction clinic and
        opting for 2-staged tissue expander/implant-based breast reconstruction or augmentation will
        be given the option of study enrollment. Consenting patients will be enrolled and randomized
        1:1 to undergo standard 2-staged breast reconstruction/ augmentation with conventional tissue
        expansion (control) or with application Blossom Smart Expander Technology (intervention) in
        the first stage reconstruction (tissue expansion).
  
        The intervention group involves the placement of the Mentor Spectrum tissue expander coupled
        with Blossom Syringe Assist device. The postoperative follow-up and subsequent surgery to
        exchange the device to a permanent implant is normal part of standard care.
  
        A Mentor Spectrum adjustable saline breast implant for expansion, coupled with the Blossom
        Syringe Assist device, will be inserted above the pectoralis major muscle in the usual
        fashion. The nature of the surgery remains identical to that employed for conventional breast
        tissue expander insertion for reconstruction or augmentation.
  
        Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with
        documentation of clinical data throughout will also take place until completion of the
        expansion, stabilization of surgical scars, and removal of all percutaneous drains.
        Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical
        practice in implant-based breast reconstruction in preparation for the second stage expander
        to definitive implant exchange.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to either undergo tissue expansion with the Blossom device (intervention group) or standard tissue expansion methods (control group).
  primary purpose: Prevention
  masking: Single (Outcomes Assessor)
  masking description: By nature of the visible device, participants and care providers cannot be blinded to the treatments. Analysis of data generated during the trial will be blinded to the treatment groups.
  measure: Time until completion of tissue expansion
  time frame: Expansion is expected to be completed between 3 and 6 months after the stage 1 surgery.
  description: The time between placement of the tissue expander (stage 1 surgery) and completion of tissue expansion will be recorded and compared between each study arm.
  measure: Incidence of complications
  time frame: Monitoring for complications will occur until removal of the tissue expander device during the second stage surgery (approximately 6 months)
  description: Any occurrence of surgical complications, such as infection, seroma, hematoma, extrusion, wound breakdown, and/ or device malfunction, etc. will be monitored and recorded in each study arm.
  measure: Patient satisfaction (BreastQ)
  time frame: Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).
  description: Patient satisfaction will be assessed using the validated BreastQ survey.
  measure: Patient satisfaction (device specific survey)
  time frame: Survey responses will be collected at standard post-operative time points (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until the second stage surgery (3 to 6 months).
  description: Patient satisfaction will be assessed using a device-specific survey.
  measure: Pain associated with tissue expansion
  time frame: Patient pain will be assessed routinely (e.g. during each post-operative visit; 1 week, 3 weeks, 6 weeks post-op) until tissue expansion is complete (3 to 6 months).
  description: Pain will be assessed using a study-specific survey.
  arm group label: Blossom tissue expander
  arm group type: Experimental
  description: The intervention group involves the placement of the Mentor Spectrum tissue expander coupled with Blossom Syringe Assist device inserted above the pectoralis major muscle in the usual fashion. The nature of the surgery remains identical to that employed for conventional breast tissue expander insertion for reconstruction or augmentation.
  Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be automatic via the Blossom device until appropriate volume is achieved. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange.
  arm group label: Standard tissue expansion
  arm group type: Active Comparator
  description: The standard tissue expansion group will undergo the same procedure with placement of the Mentor Spectrum tissue expander inserted above the pectoralis major muscle in the usual fashion. Postoperative follow-up will occur within 1 week of surgery. Weekly follow-ups with documentation of clinical data throughout will also take place until completion of the expansion, stabilization of surgical scars, and removal of all percutaneous drains. Tissue expansion will be achieved via serial injections of sterile saline into the tissue expander during postoperative follow up visits. Thereafter, follow-ups will be scheduled as needed (monthly) according to usual clinical practice in implant-based breast reconstruction in preparation for the second stage expander to definitive implant exchange. The postoperative follow-up and subsequent surgery to exchange the device to a permanent implant is normal part of standard care.
  intervention type: Device
  intervention name: Blossom tissue expander
  description: Mentor spectrum adjustable saline breast implant for expansion is placed with the Blossom tissue expander above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
  arm group label: Blossom tissue expander
  other name: Blossom smart expander device
  other name: Marz blossom syringe assist device
  other name: Blossom syringe assist device
  intervention type: Device
  intervention name: Standard tissue expansion
  description: Mentor spectrum adjustable saline breast implant for expansion is placed with (without the Blossom tissue expander) above pectoralis major during first stage surgery of an implant-based breast reconstruction/ augmentation.
  arm group label: Standard tissue expansion
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Dung H Nguyen, MD, PharmD
  phone: (650) 725-2766
  email: nguyendh@stanford.edu
  last name: Shannon Meyer, CCRC
  phone: 510-418-3831
  email: smeyer27@stanford.edu
  facility: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Stanford University
  investigator full name: Dung Nguyen
  investigator title: Clinical Professor
  sharing ipd: No