Brava and Fat Transfer for Breast Reconstruction

Fat Necrosis of Breast Clinical Trial

— Brava  

Official title:

Brava and Fat Transfer for Breast Reconstruction

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02583607
• Other study ID #: 81/15
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: October 14, 2015
• Last updated: October 20, 2015
• Start date: October 2015
• Est. completion date: October 2017

Study information

• Verified date: October 2015
• Source: Shaare Zedek Medical Center
• Contact: Yoav Gronovich, MD
• Phone: +97226666375
• Email: yoavgg[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• woman after mastectomy

Exclusion Criteria:

• smokers

• collagen disease

• low compliance

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fat Necrosis
• Fat Necrosis of Breast

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 months	No

External Links

•   The BRAVA Breast Enhancement and Shaping System