NCT05288530

Brief Summary

To explore the indications and benefits of breast reduction. The investigators suspect all of the patients in this population suffer from neck/back pain and limitations in function. The investigators also want to review the patients in this group to determine if the amount of breast tissue removed or previous breast size affects outcomes for these patients. Patients will then be contacted for outcome data and satisfaction information. Ultimately, this information may lead to improvements in management and education of patients with macromastia.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2016

Status
completed

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 Start

First participant enrolled

October 1, 2016

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
8 months until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
Last Updated

March 21, 2022

Status Verified

March 1, 2022

Enrollment Period

1.7 years

First QC Date

August 2, 2021

Last Update Submit

March 10, 2022

Conditions

MacromastiaHypertrophy Breast

Outcome Measures

Primary Outcomes (2)

  • DASH questionnaire

    Disabilities of the arm shoulder and hand, pain and function indicators

    6 months

  • Breast Q questionnaire

    quality of life questionnaire

    6 months

Eligibility Criteria

Age21 Years - 70 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients between the age of 21-70 diagnosed with hypertrophy of the breast or macromastia with surgical intervention
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Females age 21-70 with a diagnosis of hypertrophy of the breast who underwent surgical intervention

You may qualify if:

  • Females
  • Ages 21-71 years-old
  • Hypertropy of the breast
  • Macromastia
  • post-surgical intervention for macromastia or hypertrophy of the breast

You may not qualify if:

  • Males
  • BMI\>40
  • Hypertrophy of the breast but without surgical intervention
  • Macromastia but without surgical intervention

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Gigantomastia

Study Officials

  • Brannon Claytor

    Claytor Noone Plastic Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2021

First Posted

March 21, 2022

Study Start

October 1, 2016

Primary Completion

June 1, 2018

Study Completion

September 1, 2018

Last Updated

March 21, 2022

Record last verified: 2022-03