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ACTIVE NOT RECRUITING
NCT02777476
NA

Clinical Performance of B-Lite® Light Weight Breast Implant

Sponsor: G&G Biotechnology Ltd.

View on ClinicalTrials.gov

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. 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.

Key Details

Gender

FEMALE

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2016-10

Completion Date

2028-12

Last Updated

2025-09-04

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

B-Lite- Light Weight Breast Implants

Locations (3)

ETHIANUM

Heidelberg, Germany

Herzelia Medical Center

Herzliya, Israel

Akademikliniken

Stockholm, Sweden