Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Not Applicable

Completed

• Conditions: Breast Cancer; Breast Reconstruction; Nipple Reconstruction
• Interventions: Device: Nipple reconstruction

• Registration Number: NCT01216319
• Lead Sponsor: Cook Group Incorporated

Brief 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 Biodesign® Nipple Reconstruction Cylinder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Study Start: 2011-09
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2015-04-30
• Results First Submitted QC: 2015-04-30
• Results First Posted: 2015-05-15
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-19
• Last Update Posted: 2016-06-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Nipple Reconstruction Cylinder	Nipple reconstruction	-

Primary Outcome Measures

Name	Time	Method
Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)	12 months

Secondary Outcome Measures

Name	Time	Method
Rate of Patient Satisfaction	12 months	Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.

Trial Locations

Locations (4)

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States

Park Meadows Cosmetic Surgery; 🇺🇸 Lone Tree, Colorado, United States

Mercy Medical Center; 🇺🇸 Baltimore, Maryland, United States

Sanford Clinic Plastic and Reconstructive Surgery; 🇺🇸 Sioux Falls, South Dakota, United States