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Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

Nevada System of Higher Education (NSHE) logo

Nevada System of Higher Education (NSHE)

Status

Unknown

Conditions

Breast Cancer

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

The purpose of this study is to measure the level of AlloMax™ incorporation (cellular infiltration, collagen production, and neovascularization) in human breast reconstruction. The hypothesis is that the AlloMaxTM will have incorporation equivalent to adjacent breast capsule at the 3-4 month time point.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult patients (18 - 70 yrs) who require reconstructive breast surgery with AlloMaxTM implants and agree to participate will be included in this study.

Exclusion criteria

  • Patients who do not agree to be included in the study.

Trial design

60 participants in 3 patient groups

<40 years
Description:
subjects aged less than 40 years
40-60 years
Description:
subjects aged 40-60years
> 60 years
Description:
subjects aged greater than 60 years

Trial contacts and locations

1

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Central trial contact

Shelley J Williams, M.S.; Kayvan Taghipour-Khiabani, M.D.

Data sourced from clinicaltrials.gov

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