Macromastia Clinical Trial
Official title:
An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy
Verified date | October 2015 |
Source | Orbix Medical Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | Israel: Ministry of Health |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 5 |
Est. completion date | November 2015 |
Est. primary completion date | November 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 30 Years to 55 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Israel | The Plastic Surgery Department The Tel Aviv Sourasky Medical Center | Tel Aviv |
Lead Sponsor | Collaborator |
---|---|
Orbix Medical Ltd. |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measuring the aesthetic outcomes of pre /post- surgical breast ptosis | Breast measurements consists on: Breast cup size Distortions or skin retractions Symmetry between the two breasts Ptosis grade evaluated on the basis of an I-IV scale Methods to measure breast shape and symmetry Skin texture (soft or hard) Skin consistency Nipple location on the breast mound scored on a scale of 1 - 5 Areola diameter (mm) The shape of the breast scored on a scale of 1 - 5 Scar Appearance evaluation -VAS score Patient satisfaction questionnaires |
during 5 years post- surgically | No |
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