Pilot Project on the Automatic Design and 3D Printing of... | NCT06217510

Studies
Pilot Project on the Automatic Design and 3D Printing of Adolescent Idiopathic Scoliosis Braces (Phase 1)

NCT06217510

Sponsor

St. Justine's Hospital

Status

Unknown status

Last Update Posted

Jan 22, 2024Actual

Enrollment

15Estimated

Phase

Not Applicable

Conditions

Adolescent Idiopathic Scoliosis

Interventions

Test Brace

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2024Estimated

Primary Completion Date

Jun 1, 2024Estimated

Completion Date

Jun 1, 2024Estimated

First Submitted Date

Jan 8, 2024

First Submission Date that Met QC Criteria

Jan 18, 2024

First Posted Date

Jan 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 18, 2024

Last Update Posted Date

Jan 22, 2024Actual

Name	Class
Modulate Technologies	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The goal of this pilot clinical trial is to validate a 3D printed brace designed automatically for patients with Adolescent Idiopathic Scoliosis. The main question it aims to answer is: which parameters leads to a efficient and comfortable brace.

Participants will try the brace for a period of 30 minutes, measurement and feedback will be obtained.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

15Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Brace	Experimental	A 3D printed brace designed automatically from a digital twin of the participant.	Device: Test Brace

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Test Brace	Device	Participants will be fitted with the Test Brace and will wear the brace for 30 minutes.	Test Brace

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Participant Questionnaire	Questionnaire given to the participant after the testing period. Data about the experience, impressions about the brace and the comfort will be recorded.	30 minutes
Orthotist Adjustment Questionnaire	Questionnaire given to the orthotist after the testing period. Data about the number of adjustment and his experience working with the brace will be recorded.	30 minutes

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnostic of Adolescent Idiopathic Scoliosis
Risser 0-2
Cobb Angle between 20 and 40 degrees
Prescription for a brace
Able to understand French or English

Exclusion Criteria:

Grade II or higher Spondylolisthesis
Neuromuscular disease
Past spinal surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hubert Labelle, MD	Contact	1514 345-4931	4352	hubert.labelle@umontreal.ca
Soraya Barchi	Contact	1514 345-4931	4352	soraya.barchi.hsj@ssss.gouv.qc.ca

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012600	Scoliosis

Ancestor Terms

ID	Term
D013121	Spinal Curvatures
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided