In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphy… (NCT02556697) | Clinical Trial Compass
TerminatedNot Applicable
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
Stopped: Difficulty in enrolling new patients
France9 participantsStarted 2014-11-24
Plain-language summary
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. The alterations in lung microvessels are found in pulmonary involvement of scleroderma, which are the most serious complications of the disease.
In pulmonary emphysema, there are also changes in pulmonary microvasculature, which are involved in the onset and development of the disease.
The confocal endomicroscopy is an endoscopic technique which can be performed during a bronchoscopy. This technique makes it possible to observe in real time the most distal pulmonary elements at the microscopic scale. After injection of fluorescein, then the technique of observing the pulmonary microvasculature, in vivo and in situ.
The characterization of microvascular lesions in these two pathologies could improve understanding of their mechanisms and ultimately improve the early management of patients.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with scleroderma with diffuse interstitial pneumonia, indicating a bronchoscopy.
* Patients with pulmonary emphysema indication for bronchoscopy.
* Age greater than 18 years.
* Having an affiliation to social security.
* Signed informed consent.
Exclusion Criteria:
* Severe chronic respiratory insufficiency against-indicating the completion of a bronchoscopy
* Hypercapnia defined by a PaCO2 ≥ 6 kPa
* Disorders of hemostasis against-indicating performing a bronchoscopy
* Anticoagulant therapy can not be interrupted time of completion of the examination
* A history of pneumonectomy or contralateral exploration in a nonfunctional lung
* Contraindication to the injection of fluorescein (including treatment with beta-blocker eye drops or po) or one of its excipients
* History of an injection poorly tolerated fluorescein
* A history of food allergy or drug known
* Myocardial infarction \<1 month
* Unstable angina
* Pregnant or lactating woman, premenopausal women without adequate contraception
* Person under guardianship
* Patient participating in another trial / participating in another trial within 4 weeks
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
Timeframe: Day 1
2
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
Timeframe: Day 1
3
Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma