Incorporation of AlloMaxTM in Breast Reconstruction Ver8-... | NCT01679223

Studies
Incorporation of AlloMaxTM in Breast Reconstruction Ver8-15-12

NCT01679223

Sponsor

University of Nevada, Las Vegas

Status

Unknown status

Last Update Posted

Jan 9, 2015Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Breast Cancer

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2014

Primary Completion Date

Nov 2018Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Aug 31, 2012

First Submission Date that Met QC Criteria

Aug 31, 2012

First Posted Date

Sep 5, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 8, 2015

Last Update Posted Date

Jan 9, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Kayvan Taghipour-Khiabani, M.D., Tenured Associate Professor, Head of Hand and Microsurgery, University of Nevada, Las VegasPrincipal Investigator

Lead Sponsor

University of Nevada, Las VegasOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
<40 years		subjects aged less than 40 years
40-60 years		subjects aged 40-60years
> 60 years		subjects aged greater than 60 years

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hydroxyproline Concentration	Hydroxyproline will be measured in the AlloMaxTM and adjacent capsule.	3-4 months
Neoangiogenesis	Measure new blood vessels in AlloMaxTM and adjacent capsule	3-4 months
Collagen I and III	Measure collagen I and III in AlloMaxTM and adjacent capsule	3-4 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients (18 - 70 yrs) scheduled for immediate two stage breast reconstruction with AlloMaxTM are potential subjects for this study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Kayvan Taghipour-Khiabani, M.D.	Contact	702-671-2267		kkhiabani@medicine.nevada.edu
Shelley J Williams, M.S.	Contact	702-895-1445		sjwilliams@medicine.nevada.edu

Overall Officials

Name	Affiliation	Role
Kayvan Taghipour-Khiabani, M.D.	University of Nevada School of Medicine	Principal Investigator
William A Zamboni, M.D.	University of Nevada School of Medicine	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Nevada School of Medicine	Recruiting	Las Vegas	Nevada	89102-2227	United States

Condition Browse Module

MeSH Terms

ID	Term
D001943	Breast Neoplasms
D009389	Neovascularization, Pathologic

Ancestor Terms

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided