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

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

Study Overview

• Status: Withdrawn
• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Intervention / Treatment: Procedure: nasal brushing and bacteriological sample

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Créteil, France, 94000
    • Centre Hospitalier Intercommunal de Creteil
  • Le Kremlin-Bicêtre, France
    • Hôpital Bicêtre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure
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; A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The shear stresss by tracking nano-batons (mPa)	The value of the shear stress by tracking nano-batons in mPa	Day of the surgical procedure under General Anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucosal inflammation score (0 to 10)	Mucosal inflammation score and presence of polyps during endoscopy	Inclusion Visit
Presence of pus at endoscopy	Presence of pus at endoscopy	Inclusion Visit
Frequency of ciliary beat	Frequency of the ciliary beat	Day of the surgical procedure under General Anesthesia
Shear stress by Tracking microbeads (mPa)	Value of shear stress by tracking microbeads in mPa	Day of the surgical procedure under General Anesthesia
Presence of polyps at endoscopy	Presence of polyps at endoscopy	Inclusion Visit
coordination of cillary beat	Cillary beat coordination evaluated by microscopy	Day of the surgical procedure under General Anesthesia

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: Foundation for Medical Research

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2022
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: December 5, 2019
• First Submitted That Met QC Criteria: December 5, 2019
• First Posted (Actual): December 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease
• Other Study ID Numbers: R-IMPAC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No