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

NCT04191590 | Withdrawn

• 1 other identifier: R-IMPAC
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

Impact of chronic rhinosinusitis on the index of ciliary beat efficiency using fluorescent nanosticks

Conditions

Chronic Rhinosinusitis (Diagnosis)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mucosal inflammation score (0 to 10)

  Inclusion Visit

• Presence of pus at endoscopy

  Inclusion Visit

• Frequency of ciliary beat

  Day of the surgical procedure under General Anesthesia

• Shear stress by Tracking microbeads (mPa)

  Day of the surgical procedure under General Anesthesia

• Presence of polyps at endoscopy

  Inclusion Visit

Study Arms (2)

Patient with Chronic Rhinosinusitis (CRS)

OTHER

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

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.

Procedure: nasal brushing and bacteriological sample

Interventions

nasal brushing and bacteriological sample PROCEDURE

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

Patient with Chronic Rhinosinusitis (CRS); Patient without Chronic Rhinosinusitis (CRS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead
• Foundation for Medical Research: collaborator

Study Sites (2)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94000, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, France

Location

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2019
• First Posted: December 10, 2019
• Study Start: January 1, 2022
• Primary Completion: January 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 12, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)