NCT02777476

Clinical Performance of B-Lite® Light Weight Breast Implant

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: G&G Biotechnology Ltd. · Industry
• Sex: Female
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Breast Implants

Interventions

Type	Name	Description
DEVICE	B-Lite- Light Weight Breast Implants

Timeline

• Start date: 2016-10-01
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2016-05-19
• Last updated: 2025-09-04

Locations

3 sites across 3 countries: Germany, Israel, Sweden