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

Primary Purpose

Chronic Rhinosinusitis (Diagnosis)

Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
nasal brushing and bacteriological sample
Sponsored by
Centre Hospitalier Intercommunal Creteil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Rhinosinusitis (Diagnosis)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier Intercommunal de Créteil
  • Hôpital Bicêtre

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Patient with Chronic Rhinosinusitis (CRS)

Patient without Chronic Rhinosinusitis (CRS)

Arm Description

Patients with endonasal surgery scheduled under general anesthesia for an indication of 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mucosal inflammation score (0 to 10)
Mucosal inflammation score and presence of polyps during endoscopy
Presence of pus at endoscopy
Presence of pus at endoscopy
Frequency of ciliary beat
Frequency of the ciliary beat
Shear stress by Tracking microbeads (mPa)
Value of shear stress by tracking microbeads in mPa
Presence of polyps at endoscopy
Presence of polyps at endoscopy
coordination of cillary beat
Cillary beat coordination evaluated by microscopy

Full Information

First Posted
December 5, 2019
Last Updated
September 5, 2023
Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Foundation for Medical Research
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1. Study Identification

Unique Protocol Identification Number
NCT04191590
Brief Title
Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks: (R-IMPAC)
Acronym
R-IMPAC
Official Title
Impact of Chronic Rhinosinusitis on the Index of Ciliary Beat Efficiency Using Fluorescent Nanosticks
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2027 (Anticipated)
Study Completion Date
July 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Intercommunal Creteil
Collaborators
Foundation for Medical Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis (Diagnosis)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patient with Chronic Rhinosinusitis (CRS)
Arm Type
Other
Arm Description
Patients with endonasal surgery scheduled under general anesthesia for an indication of Chronic Rhinosinusitis (CRS)
Arm Title
Patient without Chronic Rhinosinusitis (CRS)
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
nasal brushing and bacteriological sample
Intervention Description
A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure
Primary Outcome Measure Information:
Title
The shear stresss by tracking nano-batons (mPa)
Description
The value of the shear stress by tracking nano-batons in mPa
Time Frame
Day of the surgical procedure under General Anesthesia
Secondary Outcome Measure Information:
Title
Mucosal inflammation score (0 to 10)
Description
Mucosal inflammation score and presence of polyps during endoscopy
Time Frame
Inclusion Visit
Title
Presence of pus at endoscopy
Description
Presence of pus at endoscopy
Time Frame
Inclusion Visit
Title
Frequency of ciliary beat
Description
Frequency of the ciliary beat
Time Frame
Day of the surgical procedure under General Anesthesia
Title
Shear stress by Tracking microbeads (mPa)
Description
Value of shear stress by tracking microbeads in mPa
Time Frame
Day of the surgical procedure under General Anesthesia
Title
Presence of polyps at endoscopy
Description
Presence of polyps at endoscopy
Time Frame
Inclusion Visit
Title
coordination of cillary beat
Description
Cillary beat coordination evaluated by microscopy
Time Frame
Day of the surgical procedure under General Anesthesia

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille JUNG, MD
Phone
01 57 02 22 68
Ext
+33
Email
camille.jung@chicreteil.fr
Facility Information:
Facility Name
Centre Hospitalier Intercommunal de Créteil
City
Créteil
ZIP/Postal Code
94000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emilie BEQUIGNON, MD
Phone
01 45 17 50 00
Ext
+33(1)
Email
emilie.bequignon@gmail.com
First Name & Middle Initial & Last Name & Degree
André COSTE, PhD
First Name & Middle Initial & Last Name & Degree
Lydia BRUGEL, MD
First Name & Middle Initial & Last Name & Degree
Héloïse DE KERMADEC, MD
First Name & Middle Initial & Last Name & Degree
Anne GAUTHIER, MD
Facility Name
Hôpital Bicêtre
City
Le Kremlin-Bicêtre
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Françoois PAPON, PhD
Email
jean-francois.papon@aphp.fr
First Name & Middle Initial & Last Name & Degree
Soo KIM, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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