Early Onset Scoliosis (EOS)Phase 3NCT06301984
Safety and Efficacy Evaluation of Insight GS Growing System
A Phase 3 study testing Insight GS in people with Early Onset Scoliosis (EOS), run by EVEREST PESQUISA E DESENVOLVIMENTO LTDA at 1 site in Brazil.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Early Onset Scoliosis (EOS)
- What is being tested?
- Insight GS
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2024to Aug 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Show all 11Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Hospital Ortopédico AACD
São Paulo, São Paulo, 04027-000
Mariana F Goncalves, mfgoncalves@aacd.org.br
Alexandre F Cristante
About this study
Official title: Safety and Efficacy Evaluation of Insight GS Growing System in the Surgical Treatment of Early Onset Scoliosis (EOS)
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).
Read more
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.
- Conditions
- Early Onset Scoliosis (EOS)
- Being tested
- Insight GS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insight GSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | 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 Receives: Device: Insight GS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Coronal Cobb angle change 24 months after installation of the Insight GS system.
To determine the Cobb angle, a line will be used on the upper edge of the most inclined upper vertebra and on the lower edge of the most inclined lower vertebra, then the lines will be crossed and the measurement of the angle where they cross is the angle of Cobb. The measurement will be performed manually using conventional radiography and measuring the angle using the Cobb ruler.
Measured: 24 months after Insight GS System placement
Secondary outcomes (4)
Number of Adverse event ocurrence assessed by clinical evaluation
Adverse event monitoring
Measured: 24 months after Insight GS System placement
Changes in patient's trunk height assessed by T1 to T12 distance and the T1 to S1 distance on full-spine radiographs
Spinal length will be assessed by measuring the T1 to T12 distance and the T1 to S1 distance on full-spine radiographs. The distance from T1 to T12 was measured as the length of a straight line joining the middle portion of the T1 vertebral end plate and the lower T12 vertebral end plate. Likewise, the distance T1 to S1 will be measured as the length of a direct line joining the middle portion of the upper end vertebral plate of T1 and the upper portion of the S1 vertebral end plate (8). The measurement will be carried out by a single operator, using conventional radiography and an analog ruler measured in centimeters.
Measured: 24 months after Insight GS System placement
Patients' pain assessed by Wong-Baker non-verbal facial scale
To measure patients' pain, the Wong-Baker non-verbal facial scale will be used
Measured: 24 months after Insight GS System placement
Patient's satisfaction assessed by EOSQ-24 scale
To assess the impact and satisfaction of treatment on caregivers or guardians, the Portuguese version of the 24-Item Early-Onset Scoliosis Questionnaire (EOSQ-24) scale will be used (10).
Measured: 24 months after Insight GS System placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startSep 2024 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Early Onset Scoliosis (EOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EVEREST PESQUISA E DESENVOLVIMENTO LTDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06301984
- Sponsor's protocol ID
- ANDROMEDA_01_2023_V1
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2024
- Last updated
- 5 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mehdian H, Haddad S, Pasku D, Nasto LA. Mid-term results of a modified self-growing rod technique for the treatment of early-onset scoliosis. Bone Joint J. 2020 Nov;102-B(11):1560-1566. doi: 10.1302/0301-620X.102B11.BJJ-2020-0412.R3.
PubMed 33135451AlNouri M, Wada K, Kumagai G, Asari T, Nitobe Y, Morishima T, Uesato R, Aoki M, Ishibashi Y. Diseases and comorbidities associated with early-onset scoliosis: a retrospective multicenter analysis. Spine Deform. 2023 Mar;11(2):481-486. doi: 10.1007/s43390-022-00613-6. Epub 2022 Nov 16.
PubMed 36380109Ruiz G, Torres-Lugo NJ, Marrero-Ortiz P, Guzman H, Olivella G, Ramirez N. Early-onset scoliosis: a narrative review. EFORT Open Rev. 2022 Aug 4;7(8):599-610. doi: 10.1530/EOR-22-0040.
PubMed 35924646McCarthy RE, Luhmann S, Lenke L, McCullough FL. The Shilla growth guidance technique for early-onset spinal deformities at 2-year follow-up: a preliminary report. J Pediatr Orthop. 2014 Jan;34(1):1-7. doi: 10.1097/BPO.0b013e31829f92dc.
PubMed 23934092Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, Shah SA, Javidan P, Kadakia RV, Day TF, Akbarnia BA. Lengthening of dual growing rods and the law of diminishing returns. Spine (Phila Pa 1976). 2011 May 1;36(10):806-9. doi: 10.1097/BRS.0b013e318214d78f.
PubMed 21336236Luhmann SJ, McCarthy RE. A Comparison of SHILLA GROWTH GUIDANCE SYSTEM and Growing Rods in the Treatment of Spinal Deformity in Children Less Than 10 Years of Age. J Pediatr Orthop. 2017 Dec;37(8):e567-e574. doi: 10.1097/BPO.0000000000000751.
PubMed 27043203undefined
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of Insight GS Growing System in the Surgical Treatment of Early Onset Scoliosis (EOS)
- ClinicalTrials.gov ID
- NCT06301984
- Acronym / sponsor ID
- ANDROMEDA_01_2023_V1
- Conditions
- Early Onset Scoliosis (EOS)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- EVEREST PESQUISA E DESENVOLVIMENTO LTDAUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Device: Insight GSIn 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 |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insight GSThe 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). | Device | Experimental |
Primary outcome
Coronal Cobb angle change 24 months after installation of the Insight GS system.
Time frame: 24 months after Insight GS System placement
To determine the Cobb angle, a line will be used on the upper edge of the most inclined upper vertebra and on the lower edge of the most inclined lower vertebra, then the lines will be crossed and the measurement of the angle where they cross is the angle of Cobb. The measurement will be performed manually using conventional radiography and measuring the angle using the Cobb ruler.
4 secondary outcomes
Number of Adverse event ocurrence assessed by clinical evaluation
Time frame: 24 months after Insight GS System placement
Changes in patient's trunk height assessed by T1 to T12 distance and the T1 to S1 distance on full-spine radiographs
Time frame: 24 months after Insight GS System placement
Patients' pain assessed by Wong-Baker non-verbal facial scale
Time frame: 24 months after Insight GS System placement
Patient's satisfaction assessed by EOSQ-24 scale
Time frame: 24 months after Insight GS System placement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
- Background: PubMed 33135451Mehdian H, Haddad S, Pasku D, Nasto LA. Mid-term results of a modified self-growing rod technique for the treatment of early-onset scoliosis. Bone Joint J. 2020 Nov;102-B(11):1560-1566. doi: 10.1302/0301-620X.102B11.BJJ-2020-0412.R3.
- Background: PubMed 36380109AlNouri M, Wada K, Kumagai G, Asari T, Nitobe Y, Morishima T, Uesato R, Aoki M, Ishibashi Y. Diseases and comorbidities associated with early-onset scoliosis: a retrospective multicenter analysis. Spine Deform. 2023 Mar;11(2):481-486. doi: 10.1007/s43390-022-00613-6. Epub 2022 Nov 16.
- Background: PubMed 35924646Ruiz G, Torres-Lugo NJ, Marrero-Ortiz P, Guzman H, Olivella G, Ramirez N. Early-onset scoliosis: a narrative review. EFORT Open Rev. 2022 Aug 4;7(8):599-610. doi: 10.1530/EOR-22-0040.
- Background: PubMed 23934092McCarthy RE, Luhmann S, Lenke L, McCullough FL. The Shilla growth guidance technique for early-onset spinal deformities at 2-year follow-up: a preliminary report. J Pediatr Orthop. 2014 Jan;34(1):1-7. doi: 10.1097/BPO.0b013e31829f92dc.
- Background: PubMed 21336236Sankar WN, Skaggs DL, Yazici M, Johnston CE 2nd, Shah SA, Javidan P, Kadakia RV, Day TF, Akbarnia BA. Lengthening of dual growing rods and the law of diminishing returns. Spine (Phila Pa 1976). 2011 May 1;36(10):806-9. doi: 10.1097/BRS.0b013e318214d78f.
- Background: PubMed 27043203Luhmann SJ, McCarthy RE. A Comparison of SHILLA GROWTH GUIDANCE SYSTEM and Growing Rods in the Treatment of Spinal Deformity in Children Less Than 10 Years of Age. J Pediatr Orthop. 2017 Dec;37(8):e567-e574. doi: 10.1097/BPO.0000000000000751.
- Backgroundundefined
- Individual participant dataSharing planned: No
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Early Onset Scoliosis (EOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Insight GS in people with Early Onset Scoliosis (EOS), run by EVEREST PESQUISA E DESENVOLVIMENTO LTDA at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 5 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariana F Goncalves (+55 11 99117-6507, mfgoncalves@aacd.org.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Coronal Cobb angle change 24 months after installation of the Insight GS system. (time frame: 24 months after Insight GS System placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06301984, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2024.