Clinical Performance of B-Lite® Light Weight Breast Implant

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02777476
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : August 2, 2018
Information provided by (Responsible Party):
G&G Biotechnology Ltd.

Brief 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, hundreds 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.

Condition or disease Intervention/treatment Phase
Breast Implants Device: B-Lite- Light Weight Breast Implants Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: procedure with B-Lite® Light Weight Breast Implant Device: B-Lite- Light Weight Breast Implants

Primary Outcome Measures :
  1. Changes in breast size measurements [ Time Frame: 3 years ]
  2. Changes in bra size measurements [ Time Frame: 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02777476

Contact: Carmit Shmuel

ETHIANUM Completed
Heidelberg, Germany
Herzelia Medical Center Recruiting
Herzliya, Israel
Contact: Miriam Srur         
Akademikliniken Recruiting
Stockholm, Sweden
Contact: Sofie Lennerlund         
Concept-Clinic Recruiting
Geneva, Switzerland
Contact: Amalia Vittoz         
United Kingdom
London Bridge Plastic Surgery Ltd Not yet recruiting
London, United Kingdom
Contact: Natalie Robinson         
Sponsors and Collaborators
G&G Biotechnology Ltd.

Responsible Party: G&G Biotechnology Ltd. Identifier: NCT02777476     History of Changes
Other Study ID Numbers: CL-010
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No