Lighter breast implants put to the test in 120 women
NCT ID NCT02777476
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study is testing B-Lite, a lighter breast implant, in 120 women who want breast augmentation for the first time. The implants are already approved in Europe and Israel. Researchers will measure changes in breast and bra size, and check for any problems. All surgeries follow standard procedures.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- B-Lite light weight breast implant (device)
- What this could lead to
- If successful, this could confirm that lighter breast implants are a safe and effective option for women seeking breast augmentation.
- What could go wrong
- This is a post-market study, not a randomized trial, so results may not apply to all patients. Implants carry risks like rupture or capsular contracture.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 120 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2016
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Akademikliniken
Stockholm, Sweden
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ETHIANUM
Heidelberg, Germany
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Herzelia Medical Center
Herzliya, Israel
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