Evaluation of Breast Reduction Techniques | NCT04509037

Studies
Evaluation of Breast Reduction Techniques

NCT04509037

Sponsor

Henry Ford Health System

Status

Withdrawn

Last Update Posted

Jul 2, 2026Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Breast Reductions

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2024

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why 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.

Expanded Access Info

Start Date

Aug 8, 2012Actual

Primary Completion Date

Jun 2, 2026Actual

Completion Date

Jun 2, 2026Actual

First Submitted Date

Jun 12, 2020

First Submission Date that Met QC Criteria

Aug 10, 2020

First Posted Date

Aug 11, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2026

Last Update Posted Date

Jul 2, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Herman Houin, MD, Principal Investigator, Henry Ford Health SystemPrincipal Investigator

Lead Sponsor

Henry Ford Health SystemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Postoperative Complication Rate	To determine if liposuction assisted breast reduction has a lower postoperative complication rate as opposed to open incision breast reduction	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.	Postoperative Period (Average of 1 year following surgery)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

Patients who underwent additional procedures simultaneously at the time of the breast reduction.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent a breast reduction between 2013 and 2019.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Henry Ford Health System		Detroit	Michigan	48202	United States

Label	Type	Description	Intervention Names
Liposuction Assisted Breast Reduction
Open Incision Breast Reduction