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

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ClinicalTrials.gov Identifier: NCT02016677
Recruitment Status : Terminated (Slow enrollment rate. Low scientific value)
First Posted : December 20, 2013
Last Update Posted : December 23, 2015
Sponsor:
Information provided by (Responsible Party):
Orbix Medical Ltd.

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.

Condition or disease
Macromastia

Detailed 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


Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy
Study Start Date : December 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

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



Primary Outcome Measures :
  1. Measuring the aesthetic outcomes of pre /post- surgical breast ptosis [ Time Frame: during 5 years post- surgically ]

    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



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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Female Patients, 30 years of age or older referred for elective breast reduction surgery and /or mastopxy
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02016677


Locations
Israel
The Plastic Surgery Department The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Orbix Medical Ltd.
Investigators
Study Director: Arik Zaretski, MD TASMC

Responsible Party: Orbix Medical Ltd.
ClinicalTrials.gov Identifier: NCT02016677     History of Changes
Other Study ID Numbers: CLI-02
First Posted: December 20, 2013    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: October 2015

Keywords provided by Orbix Medical Ltd.:
Breast reduction
Mastopexy
Sagging