MacromastiaNCT02016677
An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy
An observational study of Macromastia, run by Orbix Medical Ltd. at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 30 to 55 years, women only
- Conditions the study is for
- Macromastia
- How many people
- 5 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2013to Nov 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- Women only
- No healthy volunteers
- Adult
Study population: Female Patients, 30 years of age or older referred for elective breast reduction surgery and /or mastopxy
Who may be able to join
- 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
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Plastic Surgery Department The Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
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.
Read the 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
- Conditions
- Macromastia
- Keywords
- Breast reduction, Mastopexy, Sagging
- Medical subject headings
- Gigantomastia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| observation | no specific treatment. Long term observation the results of any breast lifting or reduction surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: during 5 years post- surgically
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionNov 2015
- Study completionNov 2015
Why it stopped: Slow enrollment rate. Low scientific value
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacromastiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Orbix Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arik Zaretski, MD, Study director, TASMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02016677
- Sponsor's protocol ID
- CLI-02
- Status last verified
- Oct 2015
- First submitted
- 10 Dec 2013
- Last updated
- 23 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy
- ClinicalTrials.gov ID
- NCT02016677
- Acronym / sponsor ID
- CLI-02
- Conditions
- Macromastia
- Keywords
- Breast reduction, Mastopexy, Sagging
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Slow enrollment rate. Low scientific value
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Orbix Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 20 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| observation | – | –no specific treatment. Long term observation the results of any breast lifting or reduction surgeries |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female Patients, 30 years of age or older referred for elective breast reduction surgery and /or mastopxy
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study was stopped early (reason given: Slow enrollment rate. Low scientific value). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Arik Zaretski, MD study director
TASMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macromastia, run by Orbix Medical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Slow enrollment rate. Low scientific value). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring the aesthetic outcomes of pre /post- surgical breast ptosis (time frame: during 5 years post- surgically). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2015.