Lung TransplantationNCT00744822
Vibration Response Imaging (VRI) in Lung Transplant Recipients
An observational study of Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
This study is a prospective, multi-center study. 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months These patients will undergo a baseline VRI recording prior to the… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lung Transplantation
- How many people
- 55 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2006to Mar 2007
- Phase
- Observational
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months
Who may be able to join
- Subjects must meet all of the following inclusion criteria to be entered into the study:
- Able and willing to read, understand, and provide written Informed Consent
- Male or Female in the age range of 18-65 years
- Subject is a lung transplant recipient who underwent single or double lung transplantation within the last 6 months
- BMI > 19
- Height of >1.55 meters
- Stable clinical condition at study baseline evaluation
Who cannot join
- Any of the following will exclude the subject from study:
- Intubated patients
- Chest wall deformation
- Spine deformation (including severe scoliosis)
- Hirsutism
- Potentially contagious skin lesion on the back
Show all 10Show fewer
- Skin lesion that would interfere with sensor placement
- Cardiac pacemaker or implantable defibrillator
- Patient is pregnant as confirmed with urine pregnancy test
- Colonization of multi-resistant bacteria (MRSA) If the subject meets all of the inclusion criteria and none of the exclusion criteria, he/she is eligible to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study is a prospective, multi-center study. 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months These patients will undergo a baseline VRI recording prior to the interventional procedure and a follow-up VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as well as before and 1 hour after any recurrent interventional procedure
Read the detailed description
- Study participants will be patients who have undergone lung transplantation during the last 6 months and are in a stable clinical position at the time of enrollment.
- Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
- The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:
- Baseline after study enrollment (VRI Recording 1 + standard evaluations).
- At each follow-up visit [1, 3, 6 months after baseline visit] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
- In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
- 1 hour after all bronchoscopic interventional procedures.
- In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
- All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take ~15 minutes [the actual recording is ~2 minutes for placement and breathing/recording].
- Standard evaluation procedures may include any of the following:
- Lung function tests (this test is required at all visits)
- Physical examination
- Bronchoscopy (e.g. transbronchial biopsy)
- CT-imaging
- Chest x-ray
- V/Q Scan (Baseline visit for single lung transplantation)
- Blood gases (this test is required at all visits)
- Blood tests
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Infections, Graft Rejection
- Medical subject headings
- Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period
Measured: 6 months
Secondary outcomes (1)
The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray].
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 posted1 Sep 2008 (estimated)
- Study startMar 2006
- Primary completionMar 2007
- Study completionMar 2007
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Deep Breeze
- Investigators
- Tobias Welte, MD, Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00744822
- Sponsor's protocol ID
- 4066
- Status last verified
- Dec 2005
- First submitted
- 28 Aug 2008
- Last updated
- 1 Sep 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vibration Response Imaging (VRI) in Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00744822
- Acronym / sponsor ID
- 4066
- Conditions
- Lung Transplantation
- Keywords
- Lung Transplantation, Infections, Graft Rejection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Deep Breeze
- Study start
- Mar 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 1 Sep 2008 (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.
This study is a prospective, multi-center study. 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months These patients will undergo a baseline VRI recording prior to the interventional procedure and a follow-up VRI at 1 hour after the interventional procedure. Furthermore, the patients will be recorded at the designated follow-up periods of 1, 3 and 6-month (+ 7 days) post-baseline visit, as well as before and 1 hour after any recurrent interventional procedure
Detailed description
- Study participants will be patients who have undergone lung transplantation during the last 6 months and are in a stable clinical position at the time of enrollment.
- Patients who meet the study inclusion and exclusion criteria will be enrolled in the study.
- The enrolled patients will be recorded with the VRI at each occurrence in which the standard procedures are performed:
- Baseline after study enrollment (VRI Recording 1 + standard evaluations).
- At each follow-up visit [1, 3, 6 months after baseline visit] during the 6 month follow-up period of the study (VRI Recordings + standard evaluations (if possible)).
- In the event of bronchoscopic intervention, then before the interventional procedure (VRI Recording 1 + standard evaluations) and before any recurrent interventional procedures (VRI Recordings + standard evaluations) during the course of the study (6-month follow-up period).
- 1 hour after all bronchoscopic interventional procedures.
- In the event of an unanticipated visit, then a VRI recording will be performed (VRI Recordings + standard evaluations).
- All subjects will be recorded according to a standard procedure; moreover, it is essential that for each subject repeatable recordings will be performed in the same manner (i.e. breathing manner and matrix placement). Each VRI recording session will take ~15 minutes [the actual recording is ~2 minutes for placement and breathing/recording].
- Standard evaluation procedures may include any of the following:
- Lung function tests (this test is required at all visits)
- Physical examination
- Bronchoscopy (e.g. transbronchial biopsy)
- CT-imaging
- Chest x-ray
- V/Q Scan (Baseline visit for single lung transplantation)
- Blood gases (this test is required at all visits)
- Blood tests
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 50 lung transplant recipients will be enrolled in the study. Subjects will be selected from lung transplant recipients, who have undergone single or double lung transplantation during the last six months
Key inclusion criteria (7 listed)
- Able and willing to read, understand, and provide written Informed Consent
- Male or Female in the age range of 18-65 years
- Subject is a lung transplant recipient who underwent single or double lung transplantation within the last 6 months
- BMI > 19
- Height of >1.55 meters
Key exclusion criteria (10 listed)
- Intubated patients
- Chest wall deformation
- Spine deformation (including severe scoliosis)
- Hirsutism
- Potentially contagious skin lesion on the back
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period
Time frame: 6 months
1 secondary outcome
The secondary objective is to compare evaluations of the lung VRI images with the results of other evaluation techniques [i.e. PFT, chest X-ray].
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 1 Sep 2008.
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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.
Tobias Welte, MD 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?
An observational study of 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 7 inclusion and 10 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 1 Sep 2008. 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.
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?
The primary study objective is to evaluate the ability of VRI lung images in single lung or double lung transplant recipients to assist the physician in detecting risk factors associated with lung transplantation during the six-month follow-up period (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 1 Sep 2008.