CompletedPhase 1

Biodegradable Stents in Lung Transplantation

Germany10 participantsStarted 2009-06

Plain-language summary

A prospective observational trial involving 10 patients is planned. Intervention "SX-ELLA Stent Degradable DV Bronchial (DV Stent)" will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway complications will be measured by bronchoscopy and documented.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Recurrent airway complication (obstructive or necrotic) after single-order double-lung transplantation (at least twice balloon-dilatation or disobliteration therapy). * Patient at least 3 months after lung transplantation and followed in MHH outpatient clinic. * Target lesion in the left or right main stem bronchus, intermediate bronchus, right or left lower lobe, left upper lobe. Multiple lesions are eligible for inclusion and treatment but DV-stent implantation in different target lesions should be at least 6 weeks apart. Exclusion Criteria: * Pregnant or breast feeding women. * Patients who are using no double-barrier method of birth control. * Previous use of a metallic stent (SEMS). * Target lesion in the middle lobe bronchus, right upper lobe, carina or trachea. * Previous use of brachytherapy or topical mitomycin. * Pats. after heart-lung transplantation.

What they're measuring

Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.

Timeframe: 6 months

Trial details

NCT IDNCT00929942

SponsorHannover Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-04

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