N/A
N=50
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
Breast Cancer · Breast Reconstruction · Nipple Reconstruction
Bottom Line
View on ClinicalTrials.gov: NCT01216319 ↗Enrolled (actual)
50
Serious AEs
2.0%
Results posted
May 2015
Primary outcome: Primary: Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) — 37.3 percentage of projection vs baseline
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nipple reconstruction (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cook Group Incorporated
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) |
37.3 | — |
| SECONDARY Rate of Patient Satisfaction |
97.8 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01216319). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.