Breast ImplantsNCT02777476
Clinical Performance of B-Lite® Light Weight Breast Implant
A study testing B-Lite- Light Weight Breast Implants in people with Breast Implants, run by G&G Biotechnology Ltd. at 3 sites in 3 countries.
Trial summary
This is a post-marketing study for B-Lite® implants that carry the EC certificate for marketing in Europe and AMAR certificate for marketing in Israel. To date, thousands of implants have already been implanted in women. The study is open for primary augmentation patients only. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Implants
- What is being tested?
- B-Lite- Light Weight Breast Implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Oct 2016to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Genetic women between the ages of 18 and 60 seeking primary breast augmentation
- Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia)
- Patient provides signed informed consent
- Patient agrees to comply with the study protocol and complete all required follow up visits, including to undergo MRI
- Patient agrees to return the device to the Sponsor should the implant have to be explanted
- The patient has realistic expectations of surgical results after discussion with investigator and is an acceptable candidate for breast augmentation.
Who cannot join
- Patients with active infection anywhere in their body
- Patient is pregnant or nursing at the time of recruitment, or has been in the 6 months preceding recruitment date, or not willing to use reliable means of contraception during the first year after surgery
- Patient was implanted with any silicone implant other than breast implants (e.g., silicone artificial joints or facial implants)
- Patient breast tissue is clinically incompatible for the procedure (e.g., tissue damage resulting from radiation, insufficient tissue coverage or compromised vascularity)
- Patient has a condition, or is under treatment for any condition, which, in the opinion of the investigator and/or consulting physician(s), may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems, possible allergies and/or extraordinary immune response to implant)
- The patient has a history of mental instability and/or history of pharmaceutical psychiatric treatment
Show all 16Show fewer
- Patient unable to understand the scope of the study and/or surgery
- The patient has any disease, including uncontrolled diabetes (e.g., HbA1c > 8%), that is clinically known to impact wound healing ability
- Patient has existing costal injuries
- Patient has abscesses, malignant tumors (cancer or recurrent metastases), clinically relevant cysts or advanced fibrotic disease or patient with BIRAD ≥3
- Are not willing to undergo further surgery for revision, if medically required
- The patient has a confirmed rheumatic disease or syndrome (e.g., SLE, Sjogren's syndrome, scleroderma, polymyositis or any connective tissue disorder, rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, any other inflammatory arthritis, fibromyalgia or chronic fatigue syndrome)
- The patient has a severe breast and upper trunk deformity
- The patient participated in an investigational trial within 90 days of enrollment
- The patient has undergone an invasive medical procedure within 90 days of enrollment.
- Aesthetic addiction, drug abuse, alcohol abuse
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
This is a post-marketing study for B-Lite® implants that carry the EC certificate for marketing in Europe and AMAR certificate for marketing in Israel. To date, thousands of implants have already been implanted in women. The study is open for primary augmentation patients only. All surgeries will be performed as per standard practice at the given study site. No parallel surgical procedures will be performed at the same session.
- Conditions
- Breast Implants
- Being tested
- B-Lite- Light Weight Breast Implants
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B-Lite- Light Weight Breast ImplantsDevice
| Study group | Role | What they receive |
|---|---|---|
| procedure with B-Lite® Light Weight Breast Implant | Experimental | Not described Receives: Device: B-Lite- Light Weight Breast Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in breast size measurements
Measured: 3 years
Changes in bra size measurements
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast ImplantsStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- G&G Biotechnology Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02777476
- Sponsor's protocol ID
- CL-010
- Status last verified
- Aug 2025
- First submitted
- 21 Apr 2016
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Reichenberger M, Heden P, Germann G. Mid- to Long-term Outcomes Following Primary Augmentation With B-Lite Lightweight Breast Implants: A Prospective Multicenter Postmarketing Clinical Follow-up Study. Aesthet Surg J. 2026 Aug 18;46(9):NP88-NP96. doi: 10.1093/asj/sjag105.
PubMed 42517198
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of B-Lite® Light Weight Breast Implant
- ClinicalTrials.gov ID
- NCT02777476
- Acronym / sponsor ID
- CL-010
- Conditions
- Breast Implants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- G&G Biotechnology Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 19 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-marketing study for B-Lite® implants that carry the EC certificate for marketing in Europe and AMAR certificate for marketing in Israel. To date, thousands of implants have already been implanted in women. The study is open for primary augmentation patients only. All surgeries will be performed as per standard practice at the given study site. No parallel surgical procedures will be performed at the same session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| procedure with B-Lite® Light Weight Breast Implant | Experimental | Device: B-Lite- Light Weight Breast Implants |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Genetic women between the ages of 18 and 60 seeking primary breast augmentation
- Patient is eligible to undergo MRI (i.e., no implanted metal or metal devices, no history of severe claustrophobia)
- Patient provides signed informed consent
- Patient agrees to comply with the study protocol and complete all required follow up visits, including to undergo MRI
- Patient agrees to return the device to the Sponsor should the implant have to be explanted
Key exclusion criteria (16 listed)
- Patients with active infection anywhere in their body
- Patient is pregnant or nursing at the time of recruitment, or has been in the 6 months preceding recruitment date, or not willing to use reliable means of contraception during the first year after surgery
- Patient was implanted with any silicone implant other than breast implants (e.g., silicone artificial joints or facial implants)
- Patient breast tissue is clinically incompatible for the procedure (e.g., tissue damage resulting from radiation, insufficient tissue coverage or compromised vascularity)
- Patient has a condition, or is under treatment for any condition, which, in the opinion of the investigator and/or consulting physician(s), may constitute an unwarranted surgical risk (e.g., unstable cardiac or pulmonary problems, possible allergies and/or extraordinary immune response to implant)
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 |
|---|---|---|
| B-Lite- Light Weight Breast Implants | Device | procedure with B-Lite® Light Weight Breast Implant |
Primary outcome
Changes in breast size measurements
Time frame: 3 years
Changes in bra size measurements
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Derived from this study: PubMed 42517198Reichenberger M, Heden P, Germann G. Mid- to Long-term Outcomes Following Primary Augmentation With B-Lite Lightweight Breast Implants: A Prospective Multicenter Postmarketing Clinical Follow-up Study. Aesthet Surg J. 2026 Aug 18;46(9):NP88-NP96. doi: 10.1093/asj/sjag105.
- Individual participant dataSharing planned: No
Related trials for Breast Implants
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
Active, not recruitingObservational study
Evaluation of the Performance and Safety of the Monobloc® - Silicone SoftOne® Breast Implants at 10 Years
Breast Augmentation, Breast Reconstruction
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.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B-Lite- Light Weight Breast Implants in people with Breast Implants, run by G&G Biotechnology Ltd. at 3 sites in 3 countries.
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 6 inclusion and 16 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany, Israel, Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Changes in breast size measurements (time frame: 3 years). The study lists 2 primary outcomes in all. 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 NCT02777476, which also lists 1 linked publication.
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 4 Sep 2025.