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

Macromastia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02016677
• Other study ID #: CLI-02
• Status: Terminated
• Phase: N/A
• First received: December 10, 2013
• Last updated: December 22, 2015
• Start date: December 2013
• Est. completion date: November 2015

Study information

• Verified date: October 2015
• Source: Orbix Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macromastia

Locations

Country	Name	City	State
Israel	The Plastic Surgery Department The Tel Aviv Sourasky Medical Center	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Orbix Medical Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

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