Brava and Fat Transfer for Breast Reconstruction

• Sponsor: Shaare Zedek Medical Center (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02583607
• Collaborator: (none)
• Enrollment: 50
• Arm: 1
• Duration (Months): 24

Study Details

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.

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Brava and Fat Transfer for Breast Reconstruction
• Study Start Date: Oct 1, 2015
• Anticipated Primary Completion Date: Oct 1, 2016
• Anticipated Study Completion Date: Oct 1, 2017

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Number of patients satisfied with breast reconstruction using Brava and fat transfer [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• woman after mastectomy

Exclusion Criteria:

• smokers

• collagen disease

• low compliance

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Shaare Zedek Medical Center

Investigators

• Study Director: Yoav Gronovich, MD, Shaare Zedek Medical Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The BRAVA Breast Enhancement and Shaping System

Publications

None provided.

• Responsible Party: Yoav Gronovich, Certified Plastic Surgeon, Shaare Zedek Medical Center
• ClinicalTrials.gov Identifier: NCT02583607
• Other Study ID Numbers: 81/15
• First Posted: Oct 22, 2015
• Last Update Posted: Oct 22, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Necrosis; Fat Necrosis

Study Results

No Results Posted as of Oct 22, 2015