Safety and Efficacy Evaluation of Insight GS Growing System

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

26

Participants

Timeline

Start Date

September 30, 2024

Primary Completion Date

June 30, 2027

Study Completion Date

August 31, 2027

Conditions
Early Onset Scoliosis (EOS)
Interventions
DEVICE

Insight GS

"The Andromeda Insight Growing System (Insight GS) is intended to treat severe, progressive multi-planar spinal deformities such as early-onset scoliosis while allowing for skeletal growth.~The Andromeda Insight Growing System consists of blades, clamps and pedicle screws used to form a distinct spinal construct in growing children. The implanted blade is used to brace the spine during growth and minimize the progression of scoliosis. The components are implanted from a posterior approach and are made from Titanium alloy (Ti6AL-4V-ELI), and High Density Polyethylene (HDPE)."

Trial Locations (1)

04027-000

Hospital Ortopédico AACD, São Paulo

All Listed Sponsors
lead

EVEREST PESQUISA E DESENVOLVIMENTO LTDA

OTHER

NCT06301984 - Safety and Efficacy Evaluation of Insight GS Growing System | Biotech Hunter | Biotech Hunter