MacromastiaNCT05288530
Satisfaction, Pain and Function Outcomes of Breast Reduction Patients
An observational study of Macromastia and Hypertrophy Breast, run by Claytor Noone Plastic Surgery.
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. Read more about this study
- Who is it for?
- Ages 21 to 70 years, women only
- Conditions the study is for
- Macromastia, Hypertrophy Breast
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Sep 2018
- 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 21 to 70 years
- Women only
- Adult, Older adult
Study population: Females age 21-70 with a diagnosis of hypertrophy of the breast who underwent surgical intervention
Who may be able to join
- Females
- Ages 21-71 years-old
- Hypertropy of the breast
- Macromastia
- post-surgical intervention for macromastia or hypertrophy of the breast
Who cannot join
- Males
- BMI>40
- Hypertrophy of the breast but without surgical intervention
- Macromastia but without surgical intervention
About this study
Official title: Satisfaction, Pain and Function Outcomes of Breast Reduction Patients: A Retrospective Chart Review and Patient Follow up
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.
- Conditions
- Macromastia, Hypertrophy Breast
- Medical subject headings
- Gigantomastia
What is being measured
The primary outcome is the main question the study is designed to answer.
DASH questionnaire
Disabilities of the arm shoulder and hand, pain and function indicators
Measured: 6 months
Breast Q questionnaire
quality of life questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study startOct 2016
- Primary completionJun 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacromastiaStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Claytor Noone Plastic Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brannon Claytor, Principal investigator, Claytor Noone Plastic Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288530
- Sponsor's protocol ID
- R17-3683B
- Status last verified
- Mar 2022
- First submitted
- 2 Aug 2021
- Last updated
- 21 Mar 2022
- 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 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction, Pain and Function Outcomes of Breast Reduction Patients: A Retrospective Chart Review and Patient Follow up
- ClinicalTrials.gov ID
- NCT05288530
- Acronym / sponsor ID
- R17-3683B
- Conditions
- Macromastia, Hypertrophy Breast
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Claytor Noone Plastic SurgeryUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 21 Mar 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 70 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Females age 21-70 with a diagnosis of hypertrophy of the breast who underwent surgical intervention
Key inclusion criteria (5 listed)
- Females
- Ages 21-71 years-old
- Hypertropy of the breast
- Macromastia
- post-surgical intervention for macromastia or hypertrophy of the breast
Key exclusion criteria (4 listed)
- Males
- BMI>40
- Hypertrophy of the breast but without surgical intervention
- Macromastia but without surgical intervention
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
DASH questionnaire
Time frame: 6 months
Disabilities of the arm shoulder and hand, pain and function indicators
Breast Q questionnaire
Time frame: 6 months
quality of life questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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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.
Brannon Claytor principal investigator
Claytor Noone Plastic Surgery
Questions about this trial
What is this clinical trial studying?
An observational study of Macromastia and Hypertrophy Breast, run by Claytor Noone Plastic Surgery.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
DASH questionnaire (time frame: 6 months). 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 21 Mar 2022.