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

Cook Group

Status: Completed

Conditions: Nipple Reconstruction; Breast Reconstruction; Breast Cancer

Treatments: Device: Nipple reconstruction

Study type: Interventional

Funder types: Industry

Identifiers

NCT01216319

09-009

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Nipple Reconstruction Cylinder

Experimental group

Treatment:

Device: Nipple reconstruction