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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02016677
Other study ID # CLI-02
Secondary ID
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


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
See also
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Completed NCT02769559 - Reduction Mammaplasty and Improved Quality of Life N/A
Completed NCT00558246 - Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures Phase 4
Recruiting NCT05898087 - Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty Phase 4