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Performance of OrbiSymm in Subjects Referred to Contra Lateral Breast Symmetrisation

NCT02649283 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-09-29

No results posted yet for this study

Summary

This is a Phase IV, multicenter, open label, non-randomized comparative group study to assess the safety and performance of the OrbiSymm system in subjects referred to contra lateral breast symmetrization involving a breast reduction following breast reconstruction post-mastectomy.

Conditions

  • Breast Asymmetry Between Native Breast and Reconstructed Breast

Interventions

DEVICE

OrbiSymm device

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.

PROCEDURE

Breast symmetrisation

Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.

Sponsors & Collaborators

  • Orbix Medical Ltd.

    lead INDUSTRY

Principal Investigators

  • Eyal Prof. Gur, M.D., Ph.D. · Medical Director, Orbix Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-10-31
Primary Completion
2019-10-31
Completion
2019-10-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02649283 on ClinicalTrials.gov