NCT07717138

Brief Summary

The purpose of the study is to understand the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and to identify them histologically.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2026

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

June 19, 2026

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Completed
Last Updated

July 21, 2026

Status Verified

June 1, 2026

Enrollment Period

2 months

First QC Date

June 19, 2026

Last Update Submit

July 16, 2026

Conditions

Keywords

SeptoplastyRhinoseptoplastyCartilageNasalOtoplastyRib grafting

Outcome Measures

Primary Outcomes (1)

  • Structural Histological Features of Septal, Costal, and Auricular Cartilage

    Structural analysis of cartilage architecture (e.g., chondrocyte distribution/density, extracellular matrix organization, perichondrium integrity) performed ex vivo on surgical waste tissue samples by histological staining, compared across the three cartilage types. No measurement is performed on participants in vivo.

    Through study completion, an average of one year

Secondary Outcomes (2)

  • Young's Modulus of Septal, Costal, and Auricular Cartilage

    Through study completion, an average of one year

  • Young's Modulus of Cartilage by Type, Patient Age, and Sex

    Through study completion, an average of 1 year

Study Arms (1)

Patients

Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.

Other: Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.

Interventions

Analysis of the biomechanical properties of septal cartilage as well as the cartilages used in nasal reconstruction and their histological identification.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients who have undergone septoplasty, rhinoseptoplasty, or otoplasty, and in whom excess cartilage was removed during the surgical procedure. This cartilage, usually destined for disposal as surgical waste, is collected with the patient's consent, in accordance with current ethical and regulatory guidelines.

You may qualify if:

  • Adult patients who have undergone septoplasty, rhinoseptoplasty, or otoplasty, and in whom excess cartilage was removed during the surgical procedure.
  • This cartilage, usually destined for disposal as surgical waste, is collected with the patient's consent, in accordance with current ethical and regulatory guidelines.

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital NOVO

Pontoise, Île-de-France Region, 95300, France

Location

Related Publications (9)

  • Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical characterisation of the human nasal cartilages; implications for tissue engineering. J Mater Sci Mater Med. 2016 Jan;27(1):11. doi: 10.1007/s10856-015-5619-8. Epub 2015 Dec 16.

    PMID: 26676857BACKGROUND
  • Griffin MF, Premakumar Y, Seifalian AM, Szarko M, Butler PE. Biomechanical Characterisation of the Human Auricular Cartilages; Implications for Tissue Engineering. Ann Biomed Eng. 2016 Dec;44(12):3460-3467. doi: 10.1007/s10439-016-1688-1. Epub 2016 Jul 14.

    PMID: 27417940BACKGROUND
  • Gunter JP, Clark CP, Friedman RM. Internal stabilization of autogenous rib cartilage grafts in rhinoplasty: a barrier to cartilage warping. Plast Reconstr Surg. 1997 Jul;100(1):161-9. doi: 10.1097/00006534-199707000-00026.

    PMID: 9207674BACKGROUND
  • Rotter N, Tobias G, Lebl M, Roy AK, Hansen MC, Vacanti CA, Bonassar LJ. Age-related changes in the composition and mechanical properties of human nasal cartilage. Arch Biochem Biophys. 2002 Jul 1;403(1):132-40. doi: 10.1016/S0003-9861(02)00263-1.

    PMID: 12061810BACKGROUND
  • Richmon JD, Sage AB, Wong VW, Chen AC, Pan C, Sah RL, Watson D. Tensile biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2005 Nov-Dec;19(6):617-22.

    PMID: 16402652BACKGROUND
  • Richmon JD, Sage A, Wong WV, Chen AC, Sah RL, Watson D. Compressive biomechanical properties of human nasal septal cartilage. Am J Rhinol. 2006 Sep-Oct;20(5):496-501. doi: 10.2500/ajr.2006.20.2932.

    PMID: 17063745BACKGROUND
  • Westreich RW, Courtland HW, Nasser P, Jepsen K, Lawson W. Defining nasal cartilage elasticity: biomechanical testing of the tripod theory based on a cantilevered model. Arch Facial Plast Surg. 2007 Jul-Aug;9(4):264-70. doi: 10.1001/archfaci.9.4.264.

    PMID: 17638761BACKGROUND
  • Chang B, Reighard C, Flanagan C, Hollister S, Zopf D. Evaluation of human nasal cartilage nonlinear and rate dependent mechanical properties. J Biomech. 2020 Feb 13;100:109549. doi: 10.1016/j.jbiomech.2019.109549. Epub 2019 Nov 29.

    PMID: 31926590BACKGROUND
  • Brown WE, Lavernia L, Bielajew BJ, Hu JC, Athanasiou KA. Human nasal cartilage: Functional properties and structure-function relationships for the development of tissue engineering design criteria. Acta Biomater. 2023 Sep 15;168:113-124. doi: 10.1016/j.actbio.2023.07.011. Epub 2023 Jul 16.

    PMID: 37454708BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cartilage

Study Officials

  • Khaled AL TABAA

    Hôpital NOVO

    PRINCIPAL INVESTIGATOR
  • Emmanuel PAUTHE

    CY Paris Université

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2026

First Posted

July 21, 2026

Study Start

June 1, 2026

Primary Completion

August 1, 2026

Study Completion

August 1, 2026

Last Updated

July 21, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations