Safety and performance of Orbix breast lifting system
Research type
Research Study
Full title
The safety and performance of the Orbix breast lifting system
IRAS ID
131629
Contact name
Jian Farhadi
Contact email
Sponsor organisation
Orbix Medical LTd
Clinicaltrials.gov Identifier
Research summary
Several surgical methods exist for correction of breast position, all involve open breast surgery, require general anesthesia, are time consuming and involve extensive intervention and significant scarring on the skin and inside the breast tissue. A need for simpler methods is currently acknowledged among plastic surgeons. The objective of the study is to evaluate the safety and performance of the ORBIX Breast Lifting System, during breast reduction, correction of breast position and during breast augmentation in open and minimally invasive breast surgeries.
The ORBIX Breast Lifting System is a minimally invasive technique which is intended to enable performance of such surgery using local or regional anesthesia, and without the need for an open surgery. Scarring after the ORBIX procedure is expected to be attenuated, as a result of the minimally invasive nature of the procedure.
This is an open-label prospective study for subjects of 20 years or older. Follow-up evaluation will be performed up to 5 years post surgery.REC name
London - Chelsea Research Ethics Committee
REC reference
13/LO/1648
Date of REC Opinion
13 Dec 2013
REC opinion
Further Information Favourable Opinion