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Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction Reconstruction

Investigation Into the Utility of Novel Body Composition Measurements in Association With Outcomes of Breast Reconstruction

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 2 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants are assigned to 1 of 2 cohorts and will be follow-up for up to 2 years."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

This study compares measurements of body composition to outcomes of breast reconstruction.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

Inclusion Criteria: 1. Patients must have histologically confirmed breast malignancy or increased risk of developing a breast malignancy. 2. Age ≥ 18 years. 3. Scheduled to undergo mastectomy with immediate breast reconstruction using a permanent implant, tissue expander, or autologous tissue (e.g. Deep Inferior Epigastric Perforator (DIEP) flap, muscle-sparing Transverse Rectus Abdominis Myocutaneous (msTRAM) flap, Profunda Artery Perforator (PAP) flap). 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Any significant medical condition or laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study. 2. Pregnant or breastfeeding. 3. Patients assigned male at birth. 4. Non-cisgender women. 5. Patients with implanted electronic medical devices (e.g. pacemaker, defibrillator). 6. Patients with prosthetic limbs.

Study sites (1)

CA