ScoliosisNCT06035952
Study of 3D Scanning for Adolescent Scoliosis
An observational study of Scoliosis, run by NSite Medical at 2 sites in United States.
Trial summary
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Scoliosis
- What is being tested?
- 3D topographical scan
- How many people
- 70 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Aug 2023to 15 Dec 2023
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Child, Adult
Study population: The study population will include children and adolescent patients 10 to 18 years old who present to a pediatric orthopedic clinic for scoliosis evaluation. This age range was chosen as it is the age range in which Adolescent Idiopathic Scoliosis commonly appears, and the device is intended for screening for this condition.
Who may be able to join
- Ages 10 and 18 years old
Who cannot join
- Scoliosis caused by another condition (e.g., secondary scoliosis)
- Parents/guardians unable to consent
- English is not the primary language (to avoid miscommunication)
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27708
Anthony Catanzano, MD, 919-613-7797, anthony.catanzano@duke.edu
- Recruiting
Stanford University School of Medicine
Palo Alto, California, 94063
Kali Tileston, 650-723-5243, kluker@stanford.edu
About this study
Official title: Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
The investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.
Read the detailed description
The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent.
If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.
- Conditions
- Scoliosis
- Being tested
- 3D topographical scan
- Keywords
- scoliosis, topographical scanning
- Medical subject headings
- Scoliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D topographical scanDiagnostic test
Subjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | This study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray. Receives: Diagnostic Test: 3D topographical scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of scanning device to predict clinically significant Cobb Angle
The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported.
Measured: Through study completion, an average of 3 months
Secondary outcomes (1)
Repeatability of 3D scan analysis
After the 3D scan is obtained, several personnel will align the scan relative to grid coordinates, and place a region of interest on the back of the scan. Measurements will be performed which will generate an asymmetry value, which is used to assess Cobb Angle correlation. The investigators will determine the repeatability of this manual scan assessment process.
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start7 Aug 2023
- Primary completion15 Oct 2023 (estimated)
- Study completion15 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScoliosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NSite Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kali Tileston, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035952
- Sponsor's protocol ID
- 54101
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Validation of 3D Body Surface Modeling for Patient Monitoring in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT06035952
- Acronym / sponsor ID
- 54101
- Conditions
- Scoliosis
- Keywords
- scoliosis, topographical scanning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- NSite MedicalIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 15 Oct 2023 (estimated)
- Study completion
- 15 Dec 2023 (estimated)
- First posted
- 13 Sep 2023 (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 investigators aim to validate three-dimensional topographical scanning technology as a tool for evaluation of scoliosis. Through the incorporation of 3D topographical technology in the measurement of deformity, the investigators hope to validate a novel approach to quantify deformity progression and provide an accessible alternative to traditional radiographic workup.
Detailed description
The study design will be prospective observational. Patients 10 to 18 years old being evaluated or followed for scoliosis will be included. Those unable to complete the consent and assent processes will not be enrolled. Members of the research team will review the clinic schedule through EPIC each week to identify eligible patients. Member of the patient's care team, such as the physician, will introduce the study to the patient. If the patient and the patient's caregivers are interested in learning more and/or participating, a member of the research team will provide study-related information and obtain informed consent via written or electronic consent, assent, and, if necessary, short form consent.
If a patient consents to participate, members of the research team will conduct the 3D topographical scan in a private room in the clinic. This involves 360 degree scans using a smartphone camera. Participants will also receive any standard of care x-rays during the visit. The investigators will then analyze the ability of the 3D smartphone scan to estimate the Cobb Angle measured on the X-ray, to infer the magnitude of the scoliosis deformity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | – | Diagnostic Test: 3D topographical scanThis study will have one cohort. This group of patients will undergo 3D scanning with a smartphone, and will also have standard of care diagnostics, such as an X-ray. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The study population will include children and adolescent patients 10 to 18 years old who present to a pediatric orthopedic clinic for scoliosis evaluation. This age range was chosen as it is the age range in which Adolescent Idiopathic Scoliosis commonly appears, and the device is intended for screening for this condition.
Key inclusion criteria (1 listed)
- Ages 10 and 18 years old
Key exclusion criteria (3 listed)
- Scoliosis caused by another condition (e.g., secondary scoliosis)
- Parents/guardians unable to consent
- English is not the primary language (to avoid miscommunication)
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 |
|---|---|---|
| 3D topographical scanSubjects will undergo a quick, radiation-free, no contact 3D scan using a smartphone. | Diagnostic test | Intervention |
Primary outcome
Accuracy of scanning device to predict clinically significant Cobb Angle
Time frame: Through study completion, an average of 3 months
The primary study endpoint, or primary outcome, is whether the 3D scan's predicted probability of clinically significant Cobb angle correlates with the ground truth radiograph obtained Cobb angle at the defined rate. The percentage (%) of patient scans with predicted probabilities that correlate with ground truth results will be reported.
1 secondary outcome
Repeatability of 3D scan analysis
Time frame: Within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Scoliosis
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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.
Kali Tileston, MD principal investigator
Stanford University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Scoliosis, run by NSite Medical at 2 sites in United States.
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 1 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael J. Gardner, MD (9175846909, mike@nsitemedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of scanning device to predict clinically significant Cobb Angle (time frame: Through study completion, an average of 3 months). 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 13 Sep 2023.