Breast ReconstructionNCT00691327

Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

A study testing Natrelle(TM) Silicone-Filled Breast Implants in people with Breast Reconstruction, run by Allergan Medical at 1 site 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

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants. Read more about this study

Who is it for?: Any age, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Reconstruction
What is being tested?: Natrelle(TM) Silicone-Filled Breast Implants
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 84,329 participants
Where: 1 siteUnited States
Study dates: Dec 1997to Dec 2012
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 Any age
Women only
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
Females seeking revision augmentation or revision reconstruction, where problems exist
Have any of the following conditions or situations present:
Post mastectomy surgical removal of the breast for cancer or other disease;
Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;
Severe ptosis requiring reconstruction;

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Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity.
Adequate tissue available to cover implants.
Saline-filled implants are not an appropriate choice.

Who cannot join

Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
Existing carcinoma of the breast, without mastectomy.
Abscess of infection in the body at the time of enrollment.
Pregnant or nursing.
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.
Show tissue characteristics which are clinically incompatible with mammaplasty.

Show all 9Show fewer

Have, or under treatment for any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
Are not willing to undergo further surgery for revision, if medically required.
Diagnosis of lupus or scleroderma.

Trial locations and contacts

1 site in 1 country.

United States1 site

Study site
Indianapolis, Indiana

Other trials in United States

About this study

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.

Conditions: Breast Reconstruction
Being tested: Natrelle(TM) Silicone-Filled Breast Implants
Keywords: Revision of augmentation or reconstruction

What participants receive

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

Natrelle(TM) Silicone-Filled Breast ImplantsDevice
Breast implant surgery

Study groups in NCT00691327
Study group	Role	What they receive
1	Experimental	Primary reconstruction Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants
2	Experimental	Revision-reconstruction Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants
3	Experimental	Revision-augmentation Receives: Device: Natrelle(TM) Silicone-Filled Breast Implants

What is being measured

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

Local Complications
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Measured: 5 years

Secondary outcomes (1)

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Measured: 5 years

Timeline

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

Dec 1997Dec 2012

First posted5 Jun 2008 (estimated)
Study startDec 1997
Primary completionDec 2012
Study completionDec 2012

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 ReconstructionStudies 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
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 84,329 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00691327
Sponsor's protocol ID: 910044
Status last verified: Dec 2013
First submitted: 3 Jun 2008
Last updated: 13 Oct 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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

Recruiting
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
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RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

All Breast Reconstruction trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
ClinicalTrials.gov ID: NCT00691327
Acronym / sponsor ID: 910044
Conditions: Breast Reconstruction
Keywords: Revision of augmentation or reconstruction
Study type: Interventional
Recruitment status: Completed
Enrolment: 84,329 participants (actual)
Lead sponsor: Allergan MedicalIndustry (pharma, biotech, devices)
Study start: Dec 1997
Primary completion: Dec 2012 (actual)
Study completion: Dec 2012 (actual)
First posted: 5 Jun 2008 (estimated)
Results: Posted 12 Feb 2014

Clinical summary

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

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary reconstruction or revision of existing breast implants.

Study design

Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
1	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsPrimary reconstruction
2	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsRevision-reconstruction
3	Experimental	Device: Natrelle(TM) Silicone-Filled Breast ImplantsRevision-augmentation

Who may qualify

Sex: Female only
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (9 listed)

Females of any age for which breast reconstruction is considered appropriate (Patients under 18 years old require parental/legal guardian consent to participate.
Females seeking revision augmentation or revision reconstruction, where problems exist
Have any of the following conditions or situations present:
Post mastectomy surgical removal of the breast for cancer or other disease;
Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity;

Key exclusion criteria (9 listed)

Advanced fibrocystic disease considered to be premalignant without accompanying subcutaneous mastectomy.
Existing carcinoma of the breast, without mastectomy.
Abscess of infection in the body at the time of enrollment.
Pregnant or nursing.
Have any disease, including uncontrolled diabetes, which is clinically known to impact wound healing ability.

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
Natrelle(TM) Silicone-Filled Breast ImplantsBreast implant surgery	Device	1, 2, 3

Primary outcome

Local Complications
Time frame: 5 years
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts

1 secondary outcome

Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Time frame: 5 years

Results and safety

Results posted to the registry on 12 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Reconstruction	45,055	42,214
Revision	39,274	36,766

Primary outcome: Local Complications

Time frame: 5 years. Number (95% Confidence Interval). Unit: Percentage by Patient

Measure	Reconstruction n = 45055	Revision n = 39274
Capsular Contracture	15.0 (14.4 to 15.6)	21.6 (20.8 to 22.3)
Asymmetry	11.1 (10.6 to 11.7)	10.7 (10.1 to 11.2)
Implant Palpability/Visibility	7.1 (6.7 to 7.6)	11.4 (10.9 to 12.1)
Implant Malposition	6.5 (6.1 to 6.9)	7.1 (6.7 to 7.6)
Wrinkling	5.6 (5.2 to 6.0)	8.9 (8.4 to 9.4)
Breast Pain	5.2 (4.8 to 5.5)	6.6 (6.1 to 7.0)

Population analysed: All enrolled patients

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
Reconstruction	0 of 45,055 (0%)	0 of 45,055 (0%)	Not reported
Revision	0 of 39,274 (0%)	0 of 39,274 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Breast Reconstruction

Recruiting
ChatGPT & Surgeon Synergy: Redefining Breast Reconstruction Consultations for Enhanced Patient Engagement and Satisfaction
Breast Cancer, Cancer of the Breast
RecruitingObservational study
The Study is an Observational Post-market Follow-up Program to Evaluate Long Term (5 Years) Safety of Mentor Breast Implants in Chinese Population
Breast Augmentation, Mammaplasty
Active, not recruiting
A Study of the Safety and Effectiveness of the Mentor Larger Size MemoryGel Ultra High Profile Breast Implants in Subjects Who Are Undergoing Primary Breast Reconstruction or Revision Reconstruction
Breast Reconstruction, Revision Breast Reconstruction
Active, not recruiting
Memory Gel and Shape Combined Cohort
Primary Breast Augmentation, Primary Breast Reconstruction
Not yet recruiting
Impact of Intraoperative Neurotization on Sensory Recovery of the Nipple and Breast Skin in Patients Undergoing Nipple Sparing Mastectomy With Immediate Implant-Based Reconstruction: NERSENSE, Prospective Randomized Control Study
Breast Cancer

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Natrelle(TM) Silicone-Filled Breast Implants in people with Breast Reconstruction, run by Allergan Medical at 1 site 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 9 inclusion and 9 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 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 12 Feb 2014). 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?

Local Complications (time frame: 5 years). 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 NCT00691327.

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 13 Oct 2014.