Lung TransplantationPhase 1NCT00929942
Biodegradable Stents in Lung Transplantation
A Phase 1 study testing SX-ELLA Stent Degradable DV Bronchial (DV Stent) in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- SX-ELLA Stent Degradable DV Bronchial (DV Stent)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jun 2009to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Benign Bronchial Airway Stenoses in Patients After Lung Transplantation With a Biodegradable Stent - a Proof of Concept Study
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.
Read the detailed description
Obstructive airway complications (OAC) (bronchial stenosis) are a significant problem in lung transplantation (LTx), and a special subset of chronic graft dysfunction. The overall rate is approximately 20% per recipient. Even though disobliteration (laser, argon-coagulation, cryotherapy) or balloon dilatation (bronchoplasty) are performed there is a high rate of recurrence. Self expandable metallic stents (SEMS) is one suggested treatment option after failed initial therapy but have a high rate of re-stenosis (50-60%). Morbidity, the risk for e.g. infection and atelectasis and lower long-term survival are often consequences in pts. treated with SEMS. No surgical options aside from re-do-transplantation are available. OAC are developing mostly in the time 3 - 6 months post Tx. The idea is a permanent but temporary therapy with replacement character of the stenosis which is given in degradable bronchial stents.
Hypothesis: New biodegradable bronchial stents are a successful treatment of benign bronchial stenosis after lung transplantation. After stent placement is further disobliteration is less frequently used during the next 6 months.
- Conditions
- Lung Transplantation
- Being tested
- SX-ELLA Stent Degradable DV Bronchial (DV Stent)
- Keywords
- lung transplantation, bronchial stenosis, biodegradable stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SX-ELLA Stent Degradable DV Bronchial (DV Stent)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| DV Stent | Experimental | 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. Receives: Device: SX-ELLA Stent Degradable DV Bronchial (DV Stent) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.
Measured: 6 months
Secondary outcomes (1)
To demonstrate mucosal healing in the first 6 months after stent insertion.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2009 (estimated)
- Study startJun 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- ELLA-CS, Czech Republic
- Investigators
- Jens T Gottlieb, M.D., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00929942
- Sponsor's protocol ID
- 5237
- Status last verified
- Jun 2009
- First submitted
- 29 Jun 2009
- Last updated
- 22 Jul 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Benign Bronchial Airway Stenoses in Patients After Lung Transplantation With a Biodegradable Stent - a Proof of Concept Study
- ClinicalTrials.gov ID
- NCT00929942
- Acronym / sponsor ID
- 5237
- Conditions
- Lung Transplantation
- Keywords
- lung transplantation, bronchial stenosis, biodegradable stent
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- ELLA-CS, Czech Republic
- Study start
- Jun 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 30 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Obstructive airway complications (OAC) (bronchial stenosis) are a significant problem in lung transplantation (LTx), and a special subset of chronic graft dysfunction. The overall rate is approximately 20% per recipient. Even though disobliteration (laser, argon-coagulation, cryotherapy) or balloon dilatation (bronchoplasty) are performed there is a high rate of recurrence. Self expandable metallic stents (SEMS) is one suggested treatment option after failed initial therapy but have a high rate of re-stenosis (50-60%). Morbidity, the risk for e.g. infection and atelectasis and lower long-term survival are often consequences in pts. treated with SEMS. No surgical options aside from re-do-transplantation are available. OAC are developing mostly in the time 3 - 6 months post Tx. The idea is a permanent but temporary therapy with replacement character of the stenosis which is given in degradable bronchial stents.
Hypothesis: New biodegradable bronchial stents are a successful treatment of benign bronchial stenosis after lung transplantation. After stent placement is further disobliteration is less frequently used during the next 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DV Stent | Experimental | Device: SX-ELLA Stent Degradable DV Bronchial (DV Stent)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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SX-ELLA Stent Degradable DV Bronchial (DV Stent)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. | Device | DV Stent |
Primary outcome
Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC.
Time frame: 6 months
1 secondary outcome
To demonstrate mucosal healing in the first 6 months after stent insertion.
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens T Gottlieb, M.D. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SX-ELLA Stent Degradable DV Bronchial (DV Stent) in people with Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Show that DV stent can be safely placed in LTx recipients and are effective in relief of symptoms associated with OAC. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2011.