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

NCT02016677 | Terminated DMC

• 1 other identifier: CLI-02
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macromastia

Keywords

Breast reduction; Mastopexy; Sagging

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

observation

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

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Female Patients, 30 years of age or older referred for elective breast reduction surgery and /or mastopxy

You may qualify if:

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

You may not qualify if:

• \. 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

Sponsors & Collaborators

• Orbix Medical Ltd.: lead

Study Sites (1)

The Plastic Surgery Department The Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Gigantomastia

Study Officials

• Arik Zaretski, MD

  TASMC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2013
• First Posted: December 20, 2013
• Study Start: December 1, 2013
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: December 23, 2015

Record last verified: 2015-10

Locations

IL (1)