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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Breast Reconstruction Neoplasms Neoplasms by Site Nipple Reconstruction Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University School of Medicine, Stanford, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nipple reconstruction

Device

Biodesign® Nipple Reconstruction Cylinder

Other names: Biodesign

Primary outcomes

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

Time frame: 12 months

Secondary outcomes

Rate of Patient Satisfaction

Time frame: 12 months

Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.

Sponsors and collaborators

Lead sponsor

Cook Group Incorporated

Industry

Registry information

Official study title

A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)

Acronym: NRC

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Oct 7, 2010
Registry last updated: Jun 23, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed