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Lighter breast implants put to the test in 120 women

NCT ID NCT02777476

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2016

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

  • Akademikliniken

    Stockholm, Sweden

  • ETHIANUM

    Heidelberg, Germany

  • Herzelia Medical Center

    Herzliya, Israel

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