Ann Arbor, MINCT06406452Now EnrollingIRB Ready

Tracheobronchomalacia Clinical Trial in Ann Arbor, MI

Access cutting-edge tracheobronchomalacia treatment through this clinical trial at a research site in Ann Arbor. Study-provided care at no cost to qualified participants.

Sponsored by University of Michigan

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Expert Care in Ann Arbor

Access tracheobronchomalacia specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related tracheobronchomalacia treatment provided free

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Check if you qualify for this tracheobronchomalacia clinical trial in Ann Arbor, MI

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Why Participate?

  • No-Cost Study Care

  • Local to Ann Arbor

    Convenient for MI residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Ann Arbor site if eligible
  4. 4Begin participation

About This Tracheobronchomalacia Study in Ann Arbor

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.

Sponsor: University of Michigan

Who Can Participate

Inclusion Criteria

Subject must have clinically significant tracheobronchomalacia and:
be unable to wean off of mechanical ventilation, and/or
be currently dependent on a tracheostomy tube, and/or
meet current indications for a tracheostomy or another surgical intervention for TBM
Subjects must have a life expectancy of at least 2 years, exclusive of TBM
Subjects must have a parent or legal guardian capable of giving consent on behalf of the subject, and must be willing and able to complete the requirements of clinical trial follow-up
Subject must have a physician willing to provide follow-up clinical data, including a bronchoscopy at 2 years
Subjects must be greater than 1 week of age and less than 4 years of age. (Infant subjects born preterm, with low birth weight, or small for gestational age are eligible for trial enrollment if their comorbidities do not present a contraindication to surgical intervention for subjects TBM and airways are of a size that can appropriately be treated with the range of splint sizes offered in this clinical trial) Patency-Based Pre-Operative Inclusion Criteria: \- Subjects must have tracheobronchomalacia in the trachea, left main bronchus, or right main bronchus a minimum patency of less than 50% in one of these regions
Screening: In order for a subject to be sent to a clinical trial site for evaluation for the clinical trial, a subject must have tracheobronchomalacia with evidence of less than 50% minimum patency based on a Computed Tomography Scan (CT), Magnetic resonance imaging (MRI), or bronchoscopic exam at referring institution confirmed by an imaging or operative note from the local physician.
At Enrollment: The subject must have tracheobronchomalacia with minimum patency of less than 50% in the trachea and/or left mainstem bronchus and/or right mainstem bronchus, based on expiration/inspiration CT performed at a clinical trial site performed during visit 1 Intra-Operative Inclusion Criteria: \- The surgeon can safely dissect out the malacic trachea or bronchus/bronchi in order to place the splint Pre-Operative

Exclusion Criteria

Subject has significant fixed anatomic tracheal stenosis
Subject has untreated complete tracheal rings
Subject has single-lung anatomy
Subject has single-ventricle cardiac anatomy
Subject has external compression due to active malignancy, active infection, or an undrained cyst
Subject has a non-bioresorbable airway stent. Recent removal of any stent will require verification of integrity of the airway wall
Subject has a contraindication to surgery other than airway compromise
Subject has a known hypersensitivity to polycaprolactone or hydroxyapatite, and/or a previous unusual reaction to bioresorbable sutures
Subject has a genetic defect of cartilage formation
Subject has significant bronchomalacia distal to the mainstem as the predominant source of subject's airway obstruction
Membranous posterior wall intrusion is the predominant form of collapse

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Ann Arbor?

Yes, this clinical trial (NCT06406452) has an active research site in Ann Arbor, MI that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Tracheobronchomalacia Treatment Options in Ann Arbor, MI

If you're searching for tracheobronchomalacia treatment options in Ann Arbor, MI, this clinical trial (NCT06406452) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Ann Arbor research site is actively enrolling participants for this clinical trial. You'll receive care from experienced tracheobronchomalacia specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all tracheobronchomalacia clinical trials near you to find additional studies recruiting in your area.

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