Bioresorbable Airway Splint Pivotal Clinical Trial

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT06406452
Status
Recruiting
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Conditions

  • Tracheobronchomalacia

Eligibility Criteria

Sex
ALL
Age
1 Week - 3 Years
Healthy Volunteers
Not accepted

Interventions

  • Bioresorbable Tracheobronchial Splint — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Jan 7, 2025
Status verified
Jan 2026
Primary completion
Sep 30, 2029
Completion
Mar 31, 2034

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Bioresorbable Tracheobronchial Splint
    Participants are admitted to the hospital for this assessment and placement of the splint.

Primary Outcome Measure

The proportion of subjects that survive to 6 months post-splinting [ Time Frame: 6 months post splint implantation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Amy Hurst, BS
[email protected]
734-232-0958
Andrea S Les, PhD
[email protected]
734-998-5585
Richard G Ohye, MD (PRINCIPAL_INVESTIGATOR)
Glenn E Green, MD (SUB_INVESTIGATOR)
Vikram Sood, MD (SUB_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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