The purpose of this study is to learn if a three-dimensional (3D) printed airway splint device made to hold open a collapsing airway is a safe and effective treatment of Tracheobronchomalacia (TBM) in children. The airway splint is bioresorbable, meaning the child's body will absorb the splint over about five years.
Other sites will be added to the registration as sites are on-boarded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Subjects will have several imaging and bronchoscopic studies and the placement of the splint will require an open-chest surgery to implant the airway splint (s). The Materialise Bioresorbable Tracheobronchial Splint is designed for an individual subject based on Computed Tomography (CT) scans taken using a specific scan protocol. Based on these 3D models, a pre-operative plan is discussed between the Materialise engineering team and the treating surgeon(s) to determine the locations and required dimensions of the splint(s). Each subject may receive up to four splints positioned on subject's trachea or mainstem bronchi. Subjects will also have several follow-up visits, and parents will be expected to regularly fill out questionnaires.
University of Michigan
Ann Arbor, Michigan, United States
RECRUITINGThe proportion of subjects that survive to 6 months post-splinting
All-cause mortality within 6 months (180 days) of splint implantation will count against this endpoint.
Time frame: 6 months post splint implantation
The Proportion of splinted regions with equal or greater than (≥) 50% average patency at approximately 4 weeks visit (window ±2 weeks) after splint implantation
This will be measured by inspiratory/expiratory cat scan (CT), where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with an absolute increase in average patency of ≥20% from pre-op to approximately 4 weeks visit (window ±2 weeks) post splint implantation
This will be measured by inspiratory/expiratory CT, where average patency is defined as: average cross-sectional area in splinted region on expiration divided by average cross-sectional area in splinted region on inspiration.
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency approximately 4 weeks visit (window ±2 weeks) post splint implantation as measured by video bronchoscopy
The percent patency is defined as: observed diameter/expected diameter based upon adjacent non-affected areas x 100, as assessed by the Imaging Core Lab.
Time frame: Approximately 4 weeks (±2 weeks) post splint implantation
The proportion of splinted regions with ≥50% minimum patency 2 years (window ± 4 months) post splint implantation
The percent patency is defined as: observed diameter/expected diameter based upon adjacent non-affected areas x 100, as assessed by the Imaging Core Lab.
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Time frame: Approximately 2 years (window ± 4 months) post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) Pre-operative (pre-op) - up to 1 year visit
This will be collected for participants (age 0-12 months) This 36-item module measures parent self-reported functioning in physical (6 items), emotional (5 items), social (4 items), and cognitive (5 items) domains, communication (3 items), and worry (5 items), as well as two scales measuring parent-reported family functioning: daily activities (3 items) and family relationships (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Time frame: Pre-op (prior to splint implementation), up to 1 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 2 year visit
This will be collected for participants (ages 13-24 months). This 45-item module measures parent self-reported physical functioning (9 items), physical symptoms (10 items), emotional functioning (12 items), and social functioning (5 items) domains, cognitive functioning (9 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Time frame: pre-op (prior to splint implementation), up to 2 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) pre-op - up to 4 year visit
This will be collected for participants (ages 2-4 years). This 21-item module measures parent self-reported physical functioning (8 items), emotional functioning (5 items), social functioning (5 items), and school functioning (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Time frame: pre-op (prior to splint implementation), up to 4 year visit post splint implantation
Pediatric Quality of Life Inventory Infant Scales (PedsQL) generic core scale post-op 2 year - up to 5 year visit
This will be collected for participants (ages 5-7 years old, 8-12 years) This 23-item module measures parent self-reported physical functioning (8 items), emotional (5 items), social functioning (5 items) and school functioning (5 items). Items are reverse-scored and linearly transformed to a 0-100 scale, such that the minimum score is 0 and the maximum score is 100. A higher score indicates better quality of life.
Time frame: 2 year, up to 5 year visit post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module pre-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Time frame: Pre-op (prior to splint implementation)
Pediatric Quality of Life (PedsQL) Family Impact Module 3 months post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Time frame: 3 months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 6-months post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Time frame: 6-months post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 1 year post-op
There are 36 questions that will be completed from a likert scale of never 0-almost always 4. The Pediatric Quality of Life Family Impact Module (PEDSQL) Score range 0-100. Higher score better quality of life.
Time frame: 1 year post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 2 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Time frame: 2 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 3 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Time frame: 3 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 4 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Time frame: 4 years post splint implantation
Pediatric Quality of Life (PedsQL) Family Impact Module 5 years post-op
The PedsQL consists of 36 items in eight dimensions: physical functioning, emotional functioning, social functioning, cognitive functioning, communication, worry, daily activities and family relationships that measures health related quality of life. The questionnaire asks how much of a problem each item has been during the past month. Each item is answered on a scale of 0 (never) to 4 (almost always) then the scores are transformed to a 0 to 100 scale, so that higher scores indicate better heath related quality of life.
Time frame: 5 years post splint implantation
The proportion of subjects with any device-related complication (DRC) at 6 months' post-implantation.
A DRC will be defined as a subset of Serious Adverse Events (SAE) that are determined to be definitely, probably, or possibly related to the device.
Time frame: 6 months post splint implantation
The proportion of subjects with any device-related complication (DRC) at 2 years post splint implantation
A DRC will be defined as a subset of Serious Adverse Events (SAE) that are determined to be definitely, probably, or possibly related to the device
Time frame: 2 years post splint implantation