Chronic Rhinosinusitis (Diagnosis)R-IMPACNCT04191590
Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)
A study testing nasal brushing and bacteriological sample in people with Chronic Rhinosinusitis (Diagnosis), run by Centre Hospitalier Intercommunal Creteil at 2 sites in France.
Trial summary
Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis (Diagnosis)
- What is being tested?
- nasal brushing and bacteriological sample
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jan 2022to 1 Sep 2026
- 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
- Patient ≥ 18 years old
- Having chronic rhinosinusitis (RCS) requiring surgical treatment. Or
- With an indication for endonasal surgery for nasal obstruction (turbinoplasty and septoplasty) or for an endonasal surgical approach
- Acceptance to participate in the protocol with signed informed consent
- Affiliated or beneficiary of a social security scheme
Who cannot join
- Refusal to participate in the study
- No one who does not speak or understand French
- Pregnant or breastfeeding woman
- Persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice.
- Simulated participation in another intervention research
Trial locations and contacts
2 sites in 1 country.
France2 sites
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
Hôpital Bicêtre
Le Kremlin-Bicêtre
About this study
Official title: Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks
Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks
Read the detailed description
To date, the assessment of ciliary beat is only possible ex vivo on epithelial cells obtained from upper airway brushing. A previous prospective study (I-IsBac) showed a change in ciliary beat (in terms of coordination and frequency) in bacterial rhinosinusitis. The study of ex-vivo ciliary movement appears to be an interesting tool to understand the pathophysiology of CSRs and to guide and evaluate treatment.
A new tool to evaluate the effectiveness of the ex-vivo lash beat has been developed. This tool measures shear stress by tracking balls along the ciliary margin.
This measurement of ex-vivo shear stress by bead tracking is a validated technique. However, microbead tracking is limited by its low spatial and temporal resolution, long measurement time and heavy post-processing of acquisition data, making this method difficult to use in clinical routine. Monitoring ex-vivo fluorescent nano-batons could represent a simpler alternative for the clinician. This measurement is now made possible by Phosphate Lanthanum Lanthanum Nano-batons (LaPO4) whose luminescence is directly proportional to the shear.
The objective of this research project is to validate this new tool in patients with CSR by comparing it to a group of control subjects free of nasal inflammation.
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Being tested
- nasal brushing and bacteriological sample
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasal brushing and bacteriological sampleProcedure or surgery
A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure
| Study group | Role | What they receive |
|---|---|---|
| Patient with Chronic Rhinosinusitis (CRS) | Other | Patients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS) Receives: Procedure: nasal brushing and bacteriological sample |
| Patient without Chronic Rhinosinusitis (CRS) | Other | Patients with endonasal surgery scheduled under general anesthesia for an indication of endonasal surgery for nasal obstruction or patients requiring an endonasal surgical approach such as pituitary adenomas for example. Receives: Procedure: nasal brushing and bacteriological sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
The shear stresss by tracking nano-batons (mPa)
The value of the shear stress by tracking nano-batons in mPa
Measured: Day of the surgical procedure under General Anesthesia
Secondary outcomes (6)
Mucosal inflammation score (0 to 10)
Mucosal inflammation score and presence of polyps during endoscopy
Measured: Inclusion Visit
Presence of pus at endoscopy
Presence of pus at endoscopy
Measured: Inclusion Visit
Frequency of ciliary beat
Frequency of the ciliary beat
Measured: Day of the surgical procedure under General Anesthesia
Shear stress by Tracking microbeads (mPa)
Value of shear stress by tracking microbeads in mPa
Measured: Day of the surgical procedure under General Anesthesia
Presence of polyps at endoscopy
Presence of polyps at endoscopy
Measured: Inclusion Visit
coordination of cillary beat
Cillary beat coordination evaluated by microscopy
Measured: Day of the surgical procedure under General Anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2019
- Study start1 Jan 2022 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Covid crisis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis (Diagnosis)Studies 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Medical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04191590
- Sponsor's protocol ID
- R-IMPAC
- Acronym
- R-IMPAC
- Status last verified
- Aug 2025
- First submitted
- 5 Dec 2019
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks
- ClinicalTrials.gov ID
- NCT04191590
- Acronym / sponsor ID
- R-IMPAC / R-IMPAC
- Conditions
- Chronic Rhinosinusitis (Diagnosis)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid crisis
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Collaborators
- Foundation for Medical Research
- Study start
- 1 Jan 2022 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 10 Dec 2019 (actual)
- 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.
Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks
Detailed description
To date, the assessment of ciliary beat is only possible ex vivo on epithelial cells obtained from upper airway brushing. A previous prospective study (I-IsBac) showed a change in ciliary beat (in terms of coordination and frequency) in bacterial rhinosinusitis. The study of ex-vivo ciliary movement appears to be an interesting tool to understand the pathophysiology of CSRs and to guide and evaluate treatment.
A new tool to evaluate the effectiveness of the ex-vivo lash beat has been developed. This tool measures shear stress by tracking balls along the ciliary margin.
This measurement of ex-vivo shear stress by bead tracking is a validated technique. However, microbead tracking is limited by its low spatial and temporal resolution, long measurement time and heavy post-processing of acquisition data, making this method difficult to use in clinical routine. Monitoring ex-vivo fluorescent nano-batons could represent a simpler alternative for the clinician. This measurement is now made possible by Phosphate Lanthanum Lanthanum Nano-batons (LaPO4) whose luminescence is directly proportional to the shear.
The objective of this research project is to validate this new tool in patients with CSR by comparing it to a group of control subjects free of nasal inflammation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Chronic Rhinosinusitis (CRS) | Other | Procedure: nasal brushing and bacteriological samplePatients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS) |
| Patient without Chronic Rhinosinusitis (CRS) | Other | Procedure: nasal brushing and bacteriological samplePatients with endonasal surgery scheduled under general anesthesia for an indication of endonasal surgery for nasal obstruction or patients requiring an endonasal surgical approach such as pituitary adenomas for example. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient ≥ 18 years old
- Acceptance to participate in the protocol with signed informed consent
- Affiliated or beneficiary of a social security scheme
Key exclusion criteria (5 listed)
- Refusal to participate in the study
- No one who does not speak or understand French
- Pregnant or breastfeeding woman
- Persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice.
- Simulated participation in another intervention research
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 |
|---|---|---|
| nasal brushing and bacteriological sampleA nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure | Procedure or surgery | Patient with Chronic Rhinosinusitis (CRS), Patient without Chronic Rhinosinusitis (CRS) |
Primary outcome
The shear stresss by tracking nano-batons (mPa)
Time frame: Day of the surgical procedure under General Anesthesia
The value of the shear stress by tracking nano-batons in mPa
6 secondary outcomes
Mucosal inflammation score (0 to 10)
Time frame: Inclusion Visit
Presence of pus at endoscopy
Time frame: Inclusion Visit
Frequency of ciliary beat
Time frame: Day of the surgical procedure under General Anesthesia
Shear stress by Tracking microbeads (mPa)
Time frame: Day of the surgical procedure under General Anesthesia
Presence of polyps at endoscopy
Time frame: Inclusion Visit
coordination of cillary beat
Time frame: Day of the surgical procedure under General Anesthesia
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasal brushing and bacteriological sample in people with Chronic Rhinosinusitis (Diagnosis), run by Centre Hospitalier Intercommunal Creteil at 2 sites 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 5 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: withdrawn, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 withdrawn before enrolling participants, so there are no results.
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 shear stresss by tracking nano-batons (mPa) (time frame: Day of the surgical procedure under General Anesthesia). 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 12 Feb 2026.