Breast CancerNRCNCT01216319

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

A study testing Nipple reconstruction in people with Breast Cancer and Breast Reconstruction, run by Cook Group Incorporated at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Breast Cancer, Breast Reconstruction, Nipple Reconstruction
What is being tested?: Nipple reconstruction
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 4 sitesUnited States
Study dates: Sep 2011to Apr 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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 locations and contacts

4 sites in 1 country.

United States4 sites

Mercy Medical Center
Baltimore, Maryland, 21202
Park Meadows Cosmetic Surgery
Lone Tree, Colorado, 80124
Sanford Clinic Plastic and Reconstructive Surgery
Sioux Falls, South Dakota, 57105
Stanford University School of Medicine
Stanford, California, 94305

Other trials in United States

About this study

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

Conditions: Breast Cancer, Breast Reconstruction, Nipple Reconstruction
Being tested: Nipple reconstruction
Keywords: Biodesign, Nipple Reconstruction, Breast Cancer, Mastectomy
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nipple reconstructionDevice
Also called Biodesign
Biodesign® Nipple Reconstruction Cylinder

Study groups in NCT01216319
Study group	Role	What they receive
Nipple Reconstruction Cylinder	Experimental	Not described Receives: Device: Nipple reconstruction

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Apr 2014

First posted7 Oct 2010 (estimated)
Study startSep 2011
Primary completionApr 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01216319
Sponsor's protocol ID: 09-009
Acronym: NRC
Status last verified: May 2016
First submitted: 5 Oct 2010
Last updated: 23 Jun 2016
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single Arm Multicenter Study Evaluating the Cook Biodesign® Nipple Reconstruction Cylinder (NRC)
ClinicalTrials.gov ID: NCT01216319
Acronym / sponsor ID: NRC / 09-009
Conditions: Breast Cancer, Breast Reconstruction, Nipple Reconstruction
Keywords: Biodesign, Nipple Reconstruction, Breast Cancer, Mastectomy
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Cook Group IncorporatedIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Apr 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 7 Oct 2010 (estimated)
Results: Posted 15 May 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nipple Reconstruction Cylinder	Experimental	Device: Nipple reconstruction

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Nipple reconstructionAlso: BiodesignBiodesign® Nipple Reconstruction Cylinder	Device	Nipple Reconstruction Cylinder

Primary outcome

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

1 secondary outcome

Rate of Patient Satisfaction
Time frame: 12 months

Results and safety

Results posted to the registry on 15 May 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nipple Reconstruction Cylinder	50	46

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

Time frame: 12 months. Mean (Standard Deviation). Unit: percentage of projection vs baseline

Measure	Nipple Reconstruction Cylinder n = 44
Value	37.3 (17.5)

Population analysed: There were two patients (three nipples) without plastic surgery matrix in place at 12MO.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nipple Reconstruction Cylinder	1 of 50 (2%)	3 of 50 (6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Cancer

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Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Geoffrey Gurtner, MD principal investigator

Stanford University

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Nipple reconstruction in people with Breast Cancer and Breast Reconstruction, run by Cook Group Incorporated at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 May 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Nipple Projection at 12 Months Compared to Baseline (1 Week Post-procedure) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01216319.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2016.