Pulmonary DiseaseMiPECSENCT02556697
In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
A study testing Bronchoscopy with in vivo confocal endomicroscopy in people with Pulmonary Disease and Pulmonary Emphysema, run by University Hospital, Rouen at 1 site in France.
Trial summary
Systemic sclerosis (SSc) is a generalized disorder of connective tissue, arterioles and microvessels, characterized by the occurrence of fibrosis and vascular obliteration phenomena. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Disease, Pulmonary Emphysema
- What is being tested?
- Bronchoscopy with in vivo confocal endomicroscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2014to 7 May 2018
- Phase
- Interventional
- 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
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Pulmonary Disease, Pulmonary Emphysema
- Being tested
- Bronchoscopy with in vivo confocal endomicroscopy
- Medical subject headings
- Lung Diseases, Pulmonary Emphysema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bronchoscopy with in vivo confocal endomicroscopyDevice
A bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma
| Study group | Role | What they receive |
|---|---|---|
| patients with a suspicion of emphysema | Experimental | A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema Receives: Device: Bronchoscopy with in vivo confocal endomicroscopy |
| patients with a suspicion of scleroderma | Experimental | A bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia Receives: Device: Bronchoscopy with in vivo confocal endomicroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
Extra-alveolar diameter of capillaries is assessed using in vivo confocal endomicroscopy
Measured: Day 1
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
Intercapillary distance is assessed using in vivo confocal endomicroscopy
Measured: Day 1
Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
Length of the capillary is assessed using in vivo confocal endomicroscopy
Measured: Day 1
Secondary outcomes (2)
Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
Alveolar diameter entries is assessed using in vivo confocal endomicroscopy
Measured: Day 1
Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma
Axial thickness of elastic fibers is assessed using in vivo confocal endomicroscopy
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2015 (estimated)
- Study start24 Nov 2014
- Primary completion7 May 2018
- Study completion7 May 2018
Why it stopped: Difficulty in enrolling new patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mathieu SALAUN, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02556697
- Sponsor's protocol ID
- 2013/093/HP
- Acronym
- MiPECSE
- Status last verified
- Apr 2026
- First submitted
- 17 Sep 2015
- Last updated
- 14 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In Vivo Endomicroscopic Description of Pulmonary Microcirculation in Systemic Sclerosis and Emphysema Patients
- ClinicalTrials.gov ID
- NCT02556697
- Acronym / sponsor ID
- MiPECSE / 2013/093/HP
- Conditions
- Pulmonary Disease, Pulmonary Emphysema
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling new patients
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 24 Nov 2014 (actual)
- Primary completion
- 7 May 2018 (actual)
- Study completion
- 7 May 2018 (actual)
- First posted
- 22 Sep 2015 (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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with a suspicion of emphysema | Experimental | Device: Bronchoscopy with in vivo confocal endomicroscopyA bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of emphysema |
| patients with a suspicion of scleroderma | Experimental | Device: Bronchoscopy with in vivo confocal endomicroscopyA bronchoscopy with in vivo confocal endomicroscopy is assessed for patient with a suspicion of sclerodermia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Bronchoscopy with in vivo confocal endomicroscopyA bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma | Device | patients with a suspicion of emphysema, patients with a suspicion of scleroderma |
Primary outcome
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma
Time frame: Day 1
Extra-alveolar diameter of capillaries is assessed using in vivo confocal endomicroscopy
Measurement of intercapillary distance of patient with pulmonary emphysema or pulmonary scleroderma
Time frame: Day 1
Intercapillary distance is assessed using in vivo confocal endomicroscopy
Measurement of length of the capillary portions of patient with pulmonary emphysema or pulmonary scleroderma
Time frame: Day 1
Length of the capillary is assessed using in vivo confocal endomicroscopy
2 secondary outcomes
Measurement of alveolar diameter entries of patient with pulmonary emphysema or pulmonary scleroderma
Time frame: Day 1
Measurement of axial thickness of elastic fibers of patient with pulmonary emphysema or pulmonary scleroderma
Time frame: Day 1
Results and safety
The study was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2026.
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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.
Mathieu SALAUN, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy with in vivo confocal endomicroscopy in people with Pulmonary Disease and Pulmonary Emphysema, run by University Hospital, Rouen at 1 site in France.
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 5 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Apr 2026. 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 France. 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 was stopped early (reason given: Difficulty in enrolling new patients). Results are not available in the source record.
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?
Measurement of extra-alveolar diameter of capillaries of patient with pulmonary emphysema or pulmonary scleroderma (time frame: Day 1). The study lists 3 primary outcomes in all. 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 14 Apr 2026.