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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05288530
Other study ID # R17-3683B
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 2016
Est. completion date September 2018

Study information

Verified date March 2022
Source Claytor Noone Plastic Surgery
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 35
Est. completion date September 2018
Est. primary completion date June 2018
Accepts healthy volunteers
Gender Female
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: - Females - Ages 21-71 years-old - Hypertropy of the breast - Macromastia - post-surgical intervention for macromastia or hypertrophy of the breast Exclusion Criteria: - Males - BMI>40 - Hypertrophy of the breast but without surgical intervention - Macromastia but without surgical intervention

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Claytor Noone Plastic Surgery

Outcome

Type Measure Description Time frame Safety issue
Primary DASH questionnaire Disabilities of the arm shoulder and hand, pain and function indicators 6 months
Primary Breast Q questionnaire quality of life questionnaire 6 months
See also
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Completed NCT02769559 - Reduction Mammaplasty and Improved Quality of Life N/A
Terminated NCT02016677 - An Observational Study Exploring the Esthetic Outcomes of Breast Reduction Surgery and /or Mastopexy N/A
Completed NCT00558246 - Study of Prineo (Dermabond Protape) Versus Sutures in Breast Procedures Phase 4
Recruiting NCT05898087 - Subpectoral Bupivacaine for Pain Management in Adolescent Reduction Mammaplasty Phase 4