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Biodegradable Airway Stent Post Lung Transplant

NCT05334199 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-04-27

No results posted yet for this study

Summary

Introduction and rationale

Benign airway stenosis or malacia is a frequent complication of lung transplantation occurring in 4-24% of patients, most often occurring two to nine months post-transplant. Initial therapeutic approach consists of conservative endobronchial treatment with recurrent balloon dilatation, radial incision, and electro cautery. For severe case of recurrent stenosis or malacia, airway stent placement can be considered. Different types of airway stent exist, for instance self-extendable metallic stent (SEMS), silicone stent and biodegradable airway stent. Conventional airway stents (SEMS, silicone) are associated with complications as granulation tissue and recurrent infections and can be difficult to remove. Newly developed biodegrabale stents are made of polydioxanone and disintegrate after a period of time are thought to have less side effects, and has been standard of care for the last few years. A sub selection of patients have been treated with conventional stent before treated with biodegradable stent.

Research question

* To assess the efficacy and efficiency of biodegradable airway stent.
* Compare occurrence of adverse events such as infection, dislocation, in stent granulation and difficulty of removal to conventional metallic or silicone stents.
* Asses if biodegradable stent lead to improvement of lung function.
* Assessment of the life span of biodegradable stents.

Conditions

  • Airway Complications Post Lung Transplant

Interventions

DEVICE

Biodegradable stent

Bronchoscopic placement of biodegradable stent in patients with airway complications after lung transplant

Sponsors & Collaborators

  • AIDS Malignancy Consortium

    collaborator NETWORK

  • University Medical Center Groningen

    lead OTHER

Principal Investigators

  • Dirk-Jan Slebos, MD, PhD · UMCG

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-02
Primary Completion
2022-03-31
Completion
2022-03-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334199 on ClinicalTrials.gov