NCT01454713

Brief Summary

Retrospective data collection of the use of Veritas in breast reconstruction surgery

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Shorter than P25 for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2011

Completed
Last Updated

April 5, 2017

Status Verified

April 1, 2017

Enrollment Period

1 year

First QC Date

October 17, 2011

Last Update Submit

April 4, 2017

Conditions

SeromaNecrosisInfection

Study Arms (1)

Veritas

Breast reconstruction with Veritas

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Consecutive patients who have undergone single-stage or two-stage breast reconstruction surgery with Veritas

You may qualify if:

  • Age 18 years or older
  • Patients who underwent mastectomy with immediate breast reconstruction using Veritas collagen matrix
  • Patients who underwent mastectomy with single stage procedures or two-stage procedures using Veritas collagen matrix

You may not qualify if:

  • Patients who underwent delayed breast reconstruction
  • Reconstruction with something other than Veritas collagen matrix
  • Breasts that were created with DIEP or TRAM procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mark M. Mofid, MD

San Diego, California, 92037, United States

Location

Michael Meininger, MD

Troy, Michigan, 48084, United States

Location

Martin Lacey, MD

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

SeromaNecrosisInfections

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mark M Mofid, MD

    UCSD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2011

First Posted

October 19, 2011

Study Start

October 1, 2010

Primary Completion

October 1, 2011

Study Completion

October 1, 2011

Last Updated

April 5, 2017

Record last verified: 2017-04

Locations

US(3)