An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy

Orbix Medical

Status: Terminated

Conditions: Macromastia

Study type: Observational

Funder types: Industry

Identifiers

NCT02016677

CLI-02

Details and patient eligibility

About

The purpose of the study is to collect data regarding the aesthetic outcomes of patients who had breast reduction surgery and /or mastopexy in terms such as scaring, patient satisfaction, breast ptosis assessment including taking photographs and filling questionnaires.

Full description

This is a prospective observational study, single center cohort to explore the aesthetic outcomes of patients who had breast reduction and / or mastopxy surgery. The surgical intervention will be determined by the clinician with no correlation to this study.

The study will focus on the aesthetic aspects of the clinical outcome resultant from the breast surgery in par course of 5 years. Scar tissue assessment and patient's reported data (satisfaction and well-being) will be collected.

Suitable patients will be assessed for study eligibility at a screening visit and, if eligible, will be scheduled for breast surgery according to the patient and surgeon discretion.

At each follow up visit, patients will undergo clinical general examination, breast and ptosis endearments, scar appearance , aesthetic evaluation. Patients will fill satisfaction questionnaires

Enrollment: 5 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Female patient older than 30 years of age.
2. Patients willing to participate as evidenced by signing the written informed consent.
3. Patient that was found by her physician illegible for breast reduction surgery and /or mastopxy

Exclusion criteria

1. Active psychiatric illness, cognitive or sensory impairment. 2. Physical impairment that may prevent filling out a paper and pencil survey or responding to interview questions

Trial design

5 participants in 1 patient group

observation

Description:

no specific treatment. Long term observation the results of any breast lifting or reduction surgeries