Clinical trial · Interventional
Evaluation of the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
NCT01216319CI-TRIAL-00022705NRCcompletedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Reconstruction | — | UNRESOLVED | — |
| Nipple Reconstruction | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nipple reconstruction | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nipple Reconstruction Cylinder
- interventionNames
- Device: Nipple reconstruction
Primary outcomes (1)
- measure
- Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure)
- timeFrame
- 12 months
Secondary outcomes (1)
- measure
- Rate of Patient Satisfaction
- timeFrame
- 12 months
- description
- Patient satisfaction is defined as patient would recommend the nipple reconstruction operation to others.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.