NCT05334199

Biodegradable Airway Stent Post Lung Transplant

Completed NA Last updated 27 April 2022

What this trial tests

NA trial testing Biodegradable stent in Airway Complications Post Lung Transplant in 20 participants. Completed in 31 March 2022.

Timeline

2 April 2019

Primary endpoint
31 March 2022

31 March 2022

Quick facts

Lead sponsor	University Medical Center Groningen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	2 April 2019
Primary completion	31 March 2022
Estimated completion	31 March 2022
Sites	2 locations across Netherlands

Drugs / interventions tested

• Biodegradable stent

Conditions studied

• Airway Complications Post Lung Transplant — all drugs for Airway Complications Post Lung Transplant →

Sponsor

University Medical Center Groningen

Who can join

18 and older, any sex, with Airway Complications Post Lung Transplant. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.