Biodegradable Airway Stent Post Lung Transplant

NCT05334199 | Completed

• 1 other identifier: 20220075
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Adverse events

  Adverse events associated with airway stents

  4 months after placement

Secondary Outcomes (3)

• Change in FEV1

  1 week post placement

• Change in FVC

  1 week post placement

• Time to need for new stent placement

  6 months after placement

Study Arms (1)

Biodegradable stent treatment group

EXPERIMENTAL

Biodegradable stent treatment group

Device: Biodegradable stent

Interventions

Biodegradable stent DEVICE

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

Biodegradable stent treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who underwent a lung transplantation and developed airway stenosis or malacia with airway stent requirement

Sponsors & Collaborators

• University Medical Center Groningen: lead
• AIDS Malignancy Consortium: collaborator

Study Sites (2)

AMC

Amsterdam, Netherlands

Location

UMCG

Groningen, Netherlands

Location

Study Officials

• Dirk-Jan Slebos, MD, PhD

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. dr.

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 19, 2022
• Study Start: April 2, 2019
• Primary Completion: March 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 27, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)