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Brava and Fat Transfer for Breast Reconstruction

Brava and Fat Transfer for Breast Reconstruction

Status
UNKNOWN
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02583607
Acronym
Brava
Enrollment
50
Registered
2015-10-22
Start date
2015-10-31
Completion date
2017-10-31
Last updated
2015-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fat Necrosis of Breast

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.

Interventions

DEVICEBrava

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.

Sponsors

Shaare Zedek Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* woman after mastectomy

Exclusion criteria

* smokers * collagen disease * low compliance

Design outcomes

Primary

MeasureTime frameDescription
Number of patients satisfied with breast reconstruction using Brava and fat transfer6 monthspatients 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.

Contacts

Primary ContactYoav Gronovich, MD
yoavgg@gmail.com+97226666375

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026