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NCT04674995: STROBE

Stent Versus Balloon Dilatation in Patients With Tracheal Benign Stenosis

Completed Last updated 4 April 2022
What this trial tests

trial testing Stent placement in Tracheal Stenosis in 66 participants. Completed in 1 December 2020.

Timeline
1 November 2012
Primary endpoint
1 November 2017
1 December 2020

Quick facts

Lead sponsorUniversity of Modena and Reggio Emilia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment66
Start date1 November 2012
Primary completion1 November 2017
Estimated completion1 December 2020

Drugs / interventions tested

Conditions studied

Sponsor

University of Modena and Reggio Emilia

Who can join

Adults 18 to 80, any sex, with Tracheal Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a retrospective, observational cohort study carried out in two operative Units of the University Hospital of Modena (Italy): the Diagnostic and Interventional Bronchoscopy Unit (Unit A) and the Otolaryngology Unit (Unit B). The two units have different protocols routinely applied to treat tracheal benign stenosis. In Unit A, endoscopic treatment is performed through mechanical dilatation via rigid bronchoscopy and further stent placing while in Unit B the endoscopic treatment is performed through balloon dilatation via direct laryngoscopy. The primary purpose was to compare the efficacy of the two technique on tracheal stenosis treatment over time. Patients were defined as "cured" if during the 2 years after 12 months since the last intervention they did not present any of the following: respiratory symptoms, need for a re-intervention or stenosis instability.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Stenting versus balloon dilatation in patients with tracheal benign stenosis: The STROBE trial.
    Marchioni A, Andrisani D, Tonelli R, Andreani A, et al · · 2022 · cited 7× · PMID 35434321 · DOI 10.1002/lio2.734

Verify or expand the search:

Other trials of Stent placement

Trials testing the same drug.

Other recruiting trials for Tracheal Stenosis

Currently open trials in the same condition.

Other University of Modena and Reggio Emilia trials

Trials by the same sponsor.

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