Biodegradable Stents in Lung Transplantation
Treatment of Benign Bronchial Airway Stenoses in Patients After Lung Transplantation With a Biodegradable Stent - a Proof of Concept Study
1 other identifier
interventional
10
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 29, 2009
CompletedFirst Posted
Study publicly available on registry
June 30, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedJuly 22, 2011
June 1, 2009
1.8 years
June 29, 2009
July 20, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.
6 months
Secondary Outcomes (1)
To demonstrate mucosal healing in the first 6 months after stent insertion.
6 months
Study Arms (1)
DV Stent
EXPERIMENTALIntervention "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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- ELLA-CS, Czech Republiccollaborator
Study Sites (1)
Hannover Medical School
Hanover, 30625, Germany
Study Officials
- PRINCIPAL INVESTIGATOR
Jens T Gottlieb, M.D.
Hannover Medical School
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 29, 2009
First Posted
June 30, 2009
Study Start
June 1, 2009
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
July 22, 2011
Record last verified: 2009-06