search
Back to results

Brava and Fat Transfer for Breast Reconstruction (Brava)

Primary Purpose

Fat Necrosis of Breast

Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Brava
Sponsored by
Shaare Zedek Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fat Necrosis of Breast

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • woman after mastectomy

Exclusion Criteria:

  • smokers
  • collagen disease
  • low compliance

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Brava and fat transfer

    Arm Description

    The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

    Outcomes

    Primary Outcome Measures

    Number of patients satisfied with breast reconstruction using Brava and fat transfer
    patients undergoing breast mastectomy will undergo breast reconstruction using the Brava and fat transfer, and will be assessed by a certified plastic surgeon who will not be a part of the study.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 14, 2015
    Last Updated
    October 20, 2015
    Sponsor
    Shaare Zedek Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02583607
    Brief Title
    Brava and Fat Transfer for Breast Reconstruction
    Acronym
    Brava
    Official Title
    Brava and Fat Transfer for Breast Reconstruction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2015
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2015 (undefined)
    Primary Completion Date
    October 2016 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shaare Zedek Medical Center

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Breast reconstruction is one of the most challenging aspects in plastic surgery. One of the most sophisticated methods of breast reconstruction is using of autologous fat grafting. Brava is a device that invented by Dr Roger Khouri, and is intended to improve the final results of fat grafting.
    Detailed Description
    The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Fat Necrosis of Breast

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Brava and fat transfer
    Arm Type
    Experimental
    Arm Description
    The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. Woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.
    Intervention Type
    Device
    Intervention Name(s)
    Brava
    Intervention Description
    The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution. woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it.
    Primary Outcome Measure Information:
    Title
    Number of patients satisfied with breast reconstruction using Brava and fat transfer
    Description
    patients undergoing breast mastectomy will undergo breast reconstruction using the Brava and fat transfer, and will be assessed by a certified plastic surgeon who will not be a part of the study.
    Time Frame
    6 months

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: woman after mastectomy Exclusion Criteria: smokers collagen disease low compliance
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yoav Gronovich, MD
    Phone
    +97226666375
    Email
    yoavgg@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yoav Gronovich, MD
    Organizational Affiliation
    Shaare Zedek Medical Center
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Links:
    URL
    http://brava.com/
    Description
    The BRAVA Breast Enhancement and Shaping System

    Learn more about this trial

    Brava and Fat Transfer for Breast Reconstruction

    We'll reach out to this number within 24 hrs