Safety and Efficacy Evaluation of Insight GS Growing System

EVEREST PESQUISA E DESENVOLVIMENTO LTDA

Status and phase: Not yet enrolling; Phase 3

Conditions: Early Onset Scoliosis (EOS)

Treatments: Device: Insight GS

Study type: Interventional

Funder types: Other

Identifiers

NCT06301984

ANDROMEDA_01_2023_V1

Details and patient eligibility

About

Premarket, interventional, single-arm clinical study, to evaluate the safety and efficacy of Insight GS Growing System in the surgical treatment of Early Onset Scoliosis (EOS). Also, to evaluate the difference in height of the spine and trunk, the success rate of the procedure, monitor adverse events and evaluate the satisfaction of the patient and care providers. 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).

Patients from 3 to 10 years of age, or who are still skeletally immature, who present early-onset scoliosis and who are considered as able to receive the surgical procedure with the Insight GS system, will be included in the study.

Patients will be screened in the outpatient setting of the study site. All participants who meet the eligibility criteria will be invited to participate in the study, which includes screening/pre-op, surgery to install the Insight GS system, and follow-up visits at 6 weeks, 2, 4, 6, 8, 10, 12,. 18 and 24 months for data collection, clinical evaluation, imaging, and monitoring of adverse events.

Enrollment: 26 estimated patients

Sex: All

Ages: 3 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• TCLE signed by parents
• Ages 3 to 10 years, or Risser 0, or Sanders 1,2,3 and 4
• Cobb angle bigger than 30°
• Thoracic spine height T1-T12 less than 22 centimeters
• Risk of thoracic insufficiency syndrome (TIS).

Exclusion criteria

• Need for fixation at occipital or cervical levels
• Risser sign greater than or equal to 1
• Sanders bigger than 4
• Previous spine surgery
• Medullary abnormalities
• Existence of malignant processes
• Local or systemic inflammations and infections, acute or chronic
• Allergy or intolerance to materials
• Non-reducible scoliosis
• Morbid obesity
• Insufficiency or absence of skin coverage

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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26 participants in 1 patient group

Experimental

Experimental group

Description:

In the initial assessment, data regarding the general health status will be collected and imaging exams (panoramic X-ray of the anteroposterior, lateral and traction spine, and X-ray of the right and left hands) and laboratory tests (blood count, coagulogram, dosage of sodium and potassium, urea and creatinine levels, AST and ALT, PCR, ESR, type I urine and urine culture) will be requested. During the preoperative consultation, measurements of the study variables will be obtained from the imaging exams), in addition to obtaining photographs of the patients. To install the Insight GS system, the surgical approach will be carried out according to the manufacturer's instructions for use, briefly described below. A posterior midline skin incision is made from the upper to the lower instrumented level. Subfascial exposure of the spine is performed, ensuring that the facet joint capsules are spared. Pedicle screws are inserted bilaterally at the cranial and caudal ends of the instrumentati

Treatment:

Device: Insight GS