Scoliosis IdiopathicNCT06521814
Globus Reflect Tether - HUD
A study testing REFLECT scoliosis correction system in people with Scoliosis Idiopathic, run by Medical University of South Carolina.
Trial summary
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Scoliosis Idiopathic
- What is being tested?
- REFLECT scoliosis correction system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
- Patients should have failed bracing and/or be intolerant to brace wear.
Who cannot join
- Pregnancy (current)
- Prior spinal or chest surgery
- MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- Associated syndrome, including Marfan Disease or Neurofibromatosis
- Sanders stage greater than 4
Show all 10Show fewer
- Thoracic curve less than 35 or greater than 60
- Lumbar curve greater than or equal to 35
- Unable or unwilling to firmly commit to returning for required follow-up visits
- Investigator judgement that the subject/family may not be a candidate for the intervention
About this study
Official title: Globus Reflect Tether - Humanitarian Use Device
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.
Read the detailed description
The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used.
- Conditions
- Scoliosis Idiopathic
- Being tested
- REFLECT scoliosis correction system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REFLECT scoliosis correction systemProcedure or surgery
(i.e. purpose of research) The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.
| Study group | Role | What they receive |
|---|---|---|
| Globus-tethering HUD patients | Experimental | The implantation of the REFLECT scoliosis tethering system in patients diagnosed with idiopathic scoliosis. Receives: Procedure: REFLECT scoliosis correction system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cobb angles
Decrease in cobb angles for patients who are actively still growing
Measured: Until patients reach the age of 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start1 Nov 2025
- Primary completion1 Nov 2025
- Study completion1 Nov 2025
Why it stopped: This study was withdrawn prior to enrollment due to challenges in initiating the project. No participants were enrolled, and no data were collected. The study will not proceed further and is being formally closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis IdiopathicStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert Murphy, Principal investigator, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521814
- Sponsor's protocol ID
- Pro00132703
- Status last verified
- Nov 2025
- First submitted
- 22 Jul 2024
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Globus Reflect Tether - Humanitarian Use Device
- ClinicalTrials.gov ID
- NCT06521814
- Acronym / sponsor ID
- Pro00132703
- Conditions
- Scoliosis Idiopathic
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn prior to enrollment due to challenges in initiating the project. No participants were enrolled, and no data were collected. The study will not proceed further and is being formally closed.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Nov 2025 (actual)
- Study completion
- 1 Nov 2025 (actual)
- First posted
- 26 Jul 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.
The purpose of this device is to treat children and adolescents with scoliosis who have growth remaining. In patients with a curvature about the spine, Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity.
Detailed description
The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. This device received an HDE exemption from the FDA and requires MUSC IRB approval to be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Globus-tethering HUD patients | Experimental | Procedure: REFLECT scoliosis correction systemThe implantation of the REFLECT scoliosis tethering system in patients diagnosed with idiopathic scoliosis. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Skeletally immature patients that require surgical treatment to obtain and maintain correction of progressive idiopathic scoliosis, with a major Cobb angle of 35 to 60 degrees whose osseous structure is dimensionally adequate to accommodate screw fixation, as determined by radiographic imaging.
- Patients should have failed bracing and/or be intolerant to brace wear.
Key exclusion criteria (10 listed)
- Pregnancy (current)
- Prior spinal or chest surgery
- MRI abnormalities (including syrinx greater than 4mm, Chiari malformation, or tethered cord)
- Neuromuscular, thoracogenic, cardiogenic scoliosis, or any other non-idiopathic scoliosis
- Associated syndrome, including Marfan Disease or Neurofibromatosis
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 |
|---|---|---|
| REFLECT scoliosis correction system(i.e. purpose of research) The Globus Reflect scoliosis correction system aims to provide curve correction for scoliosis patients who are still actively growing. Surgical correction is accomplished without spinal fusion, instead utilizing anterior vertebral body tethering. Reflect holds the convexity of the curve in place so that the concavity can grow, thereby harnessing the power of normal spine growth to correct the deformity. | Procedure or surgery | Globus-tethering HUD patients |
Primary outcome
Cobb angles
Time frame: Until patients reach the age of 18
Decrease in cobb angles for patients who are actively still growing
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
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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. This study is not recruiting at the moment.
Robert Murphy principal investigator
Medical University of South Carolina
Questions about this trial
What is this clinical trial studying?
A study testing REFLECT scoliosis correction system in people with Scoliosis Idiopathic, run by Medical University of South Carolina.
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 2 inclusion and 10 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: withdrawn, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cobb angles (time frame: Until patients reach the age of 18). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Nov 2025.