Breast ReductionsNCT04509037
Evaluation of Breast Reduction Techniques
An observational study of Breast Reductions, run by Henry Ford Health System at 1 site in United States.
Trial summary
The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Reductions
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2012to 2 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who underwent a breast reduction between 2013 and 2019.
Who may be able to join
- Patients who underwent a breast reduction between 2013 and 2019
- All patients who underwent a liposuction assisted or layered skin incision pedicled technique breast reduction.
Who cannot join
- Patients who underwent additional procedures simultaneously at the time of the breast reduction.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breast Reductions: Retrospective Evaluation of Suction Assisted Breast Reduction With Peri-Areolar Mastopexy Compared to Longer Incision Pedicle Breast Reduction Techniques
The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.
Read the detailed description
A breast reduction is a common operation with a fairly high complication rate as large incision techniques require undermined skin flaps to be closed under tension. This study is evaluation the open incision breast reduction technique to a liposuction assisted breast reduction. This study will evaluate these two breast reduction techniques in terms of complication rates, functionality, patient satisfaction, and cosmetic outcomes. Participants will be asked to complete the BREAST-Q survey regarding their breast reduction postoperatively.
- Conditions
- Breast Reductions
- Keywords
- Breast Reductions
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 |
|---|---|---|
| Liposuction Assisted Breast Reduction | Not described | |
| Open Incision Breast Reduction | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Complication Rate
To determine if liposuction assisted breast reduction has a lower postoperative complication rate as opposed to open incision breast reduction
Measured: Postoperative Period (Average of 1 year following surgery)
Breast Reduction Success Rate
To determine if liposuction assisted breast reduction has a higher success rate as opposed to open incision breast reduction based on postoperative outcomes.
Measured: Postoperative Period (Average of 1 year following surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2020
- Study start8 Aug 2012
- Primary completion2 Jun 2026
- Study completion2 Jun 2026
Why it stopped: Due to logistical and operational constraints, including insufficient personnel and resources required to conduct the prospective study activities. As a result, the prospective arm was not initiated and no participants were enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast ReductionsStudies 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
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Herman Houin, MD, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509037
- Sponsor's protocol ID
- 7372
- Status last verified
- Dec 2024
- First submitted
- 12 Jun 2020
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Reductions: Retrospective Evaluation of Suction Assisted Breast Reduction With Peri-Areolar Mastopexy Compared to Longer Incision Pedicle Breast Reduction Techniques
- ClinicalTrials.gov ID
- NCT04509037
- Acronym / sponsor ID
- 7372
- Conditions
- Breast Reductions
- Keywords
- Breast Reductions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to logistical and operational constraints, including insufficient personnel and resources required to conduct the prospective study activities. As a result, the prospective arm was not initiated and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 8 Aug 2012 (actual)
- Primary completion
- 2 Jun 2026 (actual)
- Study completion
- 2 Jun 2026 (actual)
- First posted
- 11 Aug 2020 (actual)
- 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 this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.
Detailed description
A breast reduction is a common operation with a fairly high complication rate as large incision techniques require undermined skin flaps to be closed under tension. This study is evaluation the open incision breast reduction technique to a liposuction assisted breast reduction. This study will evaluate these two breast reduction techniques in terms of complication rates, functionality, patient satisfaction, and cosmetic outcomes. Participants will be asked to complete the BREAST-Q survey regarding their breast reduction postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Liposuction Assisted Breast Reduction | – | – |
| Open Incision Breast Reduction | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent a breast reduction between 2013 and 2019.
Key inclusion criteria (2 listed)
- Patients who underwent a breast reduction between 2013 and 2019
- All patients who underwent a liposuction assisted or layered skin incision pedicled technique breast reduction.
Key exclusion criteria (1 listed)
- Patients who underwent additional procedures simultaneously at the time of the breast reduction.
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
Postoperative Complication Rate
Time frame: Postoperative Period (Average of 1 year following surgery)
To determine if liposuction assisted breast reduction has a lower postoperative complication rate as opposed to open incision breast reduction
Breast Reduction Success Rate
Time frame: Postoperative Period (Average of 1 year following surgery)
To determine if liposuction assisted breast reduction has a higher success rate as opposed to open incision breast reduction based on postoperative outcomes.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Breast Reductions, run by Henry Ford Health System at 1 site in United States.
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 2 inclusion and 1 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: withdrawn, as of the sponsor's last update on 2 Jul 2026. 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 United States. 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 withdrawn before enrolling participants, so there are no results.
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?
Postoperative Complication Rate (time frame: Postoperative Period (Average of 1 year following surgery)). The study lists 2 primary outcomes in all. 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 2 Jul 2026.