Evaluation of the Cook Biodesign Plastic Surgery Matrix

Breast Cancer Clinical Trial

— NRC  

Official title:

A Single Arm Multicenter Study Evaluating the Cook(R) Biodesign(R) Plastic Surgery Matrix

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01216319
• Other study ID #: 09-009
• Status: Completed
• Phase: N/A
• First received: October 5, 2010
• Last updated: April 30, 2015
• Start date: September 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2015
• Source: Cook
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients with a desire for nipple reconstruction following breast cancer and breast reconstruction will receive a surgical procedure to reconstruct one or both nipples utilizing the COOK(r) Biodesign(r) Nipple Reconstruction Cylinder.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient presents with a history of breast cancer, having previously completed either uni- or bi-lateral breast removal and reconstruction.

• Patient presents with a desire to obtain nipple reconstruction

• Patient is at least 18 years of age

• And other inclusion criteria

Exclusion Criteria:

• Patient is not medically fit enough for surgery under local anesthesia

• Patient is currently smoking, using tobacco products, or nicotine products (i.e. patch, gum, or nasal spray)

• Patient is pregnant, breastfeeding or planning further pregnancy during the study period

• Patient has physical allergies or cultural objections to the receipt of porcine products

• And other exclusion criteria

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Reconstruction
• Nipple Reconstruction

Intervention

Device:
• Nipple reconstruction
Biodesign® Nipple Reconstruction Cylinder

Locations

Country	Name	City	State
United States	Mercy Medical Center	Baltimore	Maryland
United States	Park Meadows Cosmetic Surgery	Lone Tree	Colorado
United States	Sanford Clinic Plastic and Reconstructive Surgery	Sioux Falls	South Dakota
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Cook

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)		12 months	No
Secondary	Rate of Patient Satisfaction	Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.	12 months	No