Recruiting

AlloMaxTM

Sponsor:

University of Nevada, Las Vegas

Code:

NCT01679223

Conditions

Breast Cancer

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Study ID

NCT01679223

Start date

Feb, 2014

Status verified date

Jan, 2015

Completion date

Nov, 2018

Anticipated

Primary completion date

Nov, 2018

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

<40 years

subjects aged less than 40 years

40-60 years

subjects aged 40-60years

> 60 years

subjects aged greater than 60 years

Primary outcome measure

  • Hydroxyproline Concentration [ Time Frame: 3-4 months ]
  • Neoangiogenesis [ Time Frame: 3-4 months ]
  • Collagen I and III [ Time Frame: 3-4 months ]

Central Contacts and Locations

Central contacts

Kayvan Taghipour-Khiabani, M.D.

702-671-2267kkhiabani@medicine.nevada.edu

Shelley J Williams, M.S.

702-895-1445sjwilliams@medicine.nevada.edu

Locations

University of Nevada School of Medicine

Recruiting

Las Vegas, Nevada, United States, 89102-2227

Contacts

Sherree Mounts, LPN

702-671-5117smounts@medicine.nevada.edu

Principal Investigator:

Kayvan Taghipour-Khiabani, M.D.

More Information

Sponsor

University of Nevada, Las Vegas

Last update posted

Jan 9, 2015

Last verified

Jan, 2015

Keywords

  • Breast reconstruction
  • Hydroxyproline concentration
  • neoangiogenesis
  • collagen deposition

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Nevada, Las Vegas on 2015-01-09.