NCT04509037

Brief Summary

The purpose of this study is to retrospectively evaluate breast reduction techniques in terms of complications, functionality, patient satisfaction, and cosmetic outcomes.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
490

participants targeted

Target at P75+ for all trials

Timeline
2mo left

Started Aug 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress99%
Aug 2012Jun 2026

Study Start

First participant enrolled

August 8, 2012

Completed
7.8 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2020

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 11, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Expected
Last Updated

December 11, 2024

Status Verified

December 1, 2024

Enrollment Period

13.4 years

First QC Date

June 12, 2020

Last Update Submit

December 6, 2024

Conditions

Keywords

Breast Reductions

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

Liposuction Assisted Breast Reduction

Open Incision Breast Reduction

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who underwent a breast reduction between 2013 and 2019.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Henry Ford Health System

Detroit, Michigan, 48202, United States

RECRUITING

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 12, 2020

First Posted

August 11, 2020

Study Start

August 8, 2012

Primary Completion

December 12, 2025

Study Completion (Estimated)

June 12, 2026

Last Updated

December 11, 2024

Record last verified: 2024-12

Locations