CClinicalTrials.gg
WithdrawnNCT04191590R-IMPACUpdated Feb 12, 2026

Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)

An interventional study of nasal brushing and bacteriological sample in Chronic Rhinosinusitis (Diagnosis), sponsored by Centre Hospitalier Intercommunal Creteil. Withdrawn at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-12.

Sponsored by Centre Hospitalier Intercommunal Creteil · Not applicable, Interventional, and Diagnostic

Why this study was withdrawn
Covid crisis
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Chronic Rhinosinusitis (Diagnosis)

Browse trials for

03

In context

Disease

1,327 studies on the registry are indexed under Disease; 596 are open to participants now.

Browse Disease studies →

Lead sponsor

Centre Hospitalier Intercommunal Creteil is the lead sponsor of 131 studies on the registry; 36 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. 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
  2. Acceptance to participate in the protocol with signed informed consent
  3. Affiliated or beneficiary of a social security scheme

Exclusion criteria

Exclusion Criteria:

  1. Refusal to participate in the study
  2. No one who does not speak or understand French
  3. Pregnant or breastfeeding woman
  4. Persons who are incapable of reaching the age of majority, under guardianship, guardianship or protection of justice.
  5. Simulated participation in another intervention research
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Other
    Patient with Chronic Rhinosinusitis (CRS)

    Patients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS)

    Procedure: nasal brushing and bacteriological sample

  • Other
    Patient without Chronic Rhinosinusitis (CRS)

    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.

    Procedure: nasal brushing and bacteriological sample

Interventions

  • Procedurenasal brushing and bacteriological sample

    A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure

06

What researchers measure

Primary outcomes

  1. The shear stresss by tracking nano-batons (mPa)

    The value of the shear stress by tracking nano-batons in mPa

    Time frame: Day of the surgical procedure under General Anesthesia

Secondary outcomes

  1. Mucosal inflammation score (0 to 10)

    Mucosal inflammation score and presence of polyps during endoscopy

    Time frame: Inclusion Visit

  2. Presence of pus at endoscopy

    Presence of pus at endoscopy

    Time frame: Inclusion Visit

  3. Frequency of ciliary beat

    Frequency of the ciliary beat

    Time frame: Day of the surgical procedure under General Anesthesia

  4. Shear stress by Tracking microbeads (mPa)

    Value of shear stress by tracking microbeads in mPa

    Time frame: Day of the surgical procedure under General Anesthesia

  5. Presence of polyps at endoscopy

    Presence of polyps at endoscopy

    Time frame: Inclusion Visit

  6. coordination of cillary beat

    Cillary beat coordination evaluated by microscopy

    Time frame: Day of the surgical procedure under General Anesthesia

07

Study locations

2 sites
  • Centre Hospitalier Intercommunal de Créteil
    Créteil, 94000, France
  • Hôpital Bicêtre
    Le Kremlin-Bicêtre, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 12, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04191590
Lead sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Foundation for Medical Research
Responsible party
Sponsor
First posted
Dec 10, 2019
Start date
Jan 1, 2022 (estimated)
Primary completion
Jan 1, 2026 (estimated)
Completion
Sep 1, 2026 (estimated)
Last update
Feb 12, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion