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Trial record 89 of 419 for:    shaare zedek

Brava and Fat Transfer for Breast Reconstruction (Brava)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02583607
Recruitment Status : Unknown
Verified October 2015 by Yoav Gronovich, Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Yoav Gronovich, Shaare Zedek Medical Center

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.

Condition or disease Intervention/treatment Phase
Fat Necrosis of Breast Device: Brava Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Brava and Fat Transfer for Breast Reconstruction
Study Start Date : October 2015
Estimated Primary Completion Date : October 2016
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Brava and fat transfer

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.

Device: Brava

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 Measures :
  1. Number of patients satisfied with breast reconstruction using Brava and fat transfer [ Time Frame: 6 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • woman after mastectomy

Exclusion Criteria:

  • smokers
  • collagen disease
  • low compliance

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583607


Contacts
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Contact: Yoav Gronovich, MD +97226666375 yoavgg@gmail.com

Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Study Director: Yoav Gronovich, MD Shaare Zedek Medical Center

Additional Information:
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Responsible Party: Yoav Gronovich, Certified Plastic Surgeon, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT02583607     History of Changes
Other Study ID Numbers: 81/15
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: October 22, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
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Necrosis
Fat Necrosis
Pathologic Processes