Nasal SeptumPhase 2NASEPTNCT01234415
Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
A Phase 2 study testing Rhinoplasty in people with Nasal Septum, run by University Hospital, Bordeaux at 3 sites in France.
Trial summary
The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Nasal Septum
- What is being tested?
- Rhinoplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesFrance
- Study dates
- Sep 2011to Nov 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Men and women between 18 and 60
- Indication of tissue replacement in a nasal septum, which skeleton is lacking or non usable for patients having:
- Paradoxal nasal obstruction with saddle nose type III and IV or flabby nose
- Nasal obstruction with an obstacle caused by a moved multifracture skeleton
- Written informed consent
- Patient with social insurance
Who cannot join
- Post-menopausal women : lack of efficient contraception (intra uterine dispositive or contraceptive pill)
- Breast feeding or pregnant women
- HIV or VHB or VHC seropositive subject
- Inflammatory or infectious active rhino sinusitis
- Nasal an sinus surgery or trauma ended from less than 8 months
- Toxic medicated Rhinitis to vasoconstrictors
Show all 13Show fewer
- Diabetic : all type of diabetes (without or with therapy)
- Non treated cardiac disease
- Any contra indication to surgery
- Any contra indication to the biomaterial use like evolutive infection, bone disease or local necrosis
- Radiotherapy antecedent of the cephalic and cervical extremity
- Local or regional therapy with corticoids currently, or stopped from less than 2 months
- Patient participating to another study with an exclusion period still going on during pre-inclusion period
Trial locations and contacts
3 sites in 1 country.
France3 sites
Service d'Oto-rhino-laryngologie et Chirurgie cervico-faciale - CHU de Bordeaux
Bordeaux, 330176
Service d'Oto-rhino-laryngologie - Clinique St Augustin
Bordeaux, 33074
Service d'Oto-rhino-laryngologie - Hôpital Dupuytren
Limoges, 87042
About this study
Official title: Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction
The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.
Read the detailed description
Five to ten percent of the post-traumatic septo-rhinoplasties require a total reconstruction of the septal skeleton. This surgery requires using autologous bone graft (iliac, costal, or parietal). However these swabs include surgical risks, have a particular morbidity non negligible and particular quality imperfections (resorption level, texture, shape, integration) requiring a complex and long lasting shaping before implantation. To avoid the using of bone graft, a large scale of products has been developed to propose a synthetic bone substitute as a support for bone reconstruction. The bone substitute, BCP, made of hydroxyl apatite (HAP) and tricalcium phosphate (TCP), is thus largely used in orthopaedics, and CE marked in numerous indications (like sinus lift). The stake is to validate that it can be used in septo-rhino-plasties. This septic zone presents characteristics which required in vitro and in vivo studies, showing that the conclusions are a good biocompatibility of BCP for human epithelial cells and in septal area of rabbits and sheep. The ultimate step to validate this concept consists in conducting a pilot clinical study on 25 patients with the indication of septoplasties to verify its safety and efficacy in clinical conditions. This study will have an 18 months inclusion period and 6 months of follow up. The principal objective is to assess the HAP/TCP biomaterial safety and to confirm clinically and histologically the good affinity of human epithelial cells for this material. Secondary objective is to demonstrate that the restoration of the normal nasal anatomy with the material re-establishes the nasal respiratory shape and function. Clinical data, questionnaires, and photos will be collected pre operatively and at day 4, 10, and month 2 and 6 after surgery. The endonasal biopsy and fiberoptic endoscopy will be realised at 2 and 6 months post operatively and will be supplementary to the routine care protocol of the surgeon.
- Conditions
- Nasal Septum
- Being tested
- Rhinoplasty
- Keywords
- nasal, septum, reconstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RhinoplastyDevice
Rhinoplasty is performed under general anaesthesia; the duration is 1 to 2 hours. The surgical approach for implantation of the biomaterial is external rhinoplasty. The incision is made at the columella (base of nose) and becomes internal for the scar to be as unobtrusive as possible. The septum skeleton is then destroyed in order to place the synthetic biomaterial. The biomaterial is remodelled in order to have a natural external aspect of the nose. The incision is closed and the wicks are put in place in the nose for 4 days. A cast and a sticker will be put in place after surgery to maintain properly the biomaterial.
| Study group | Role | What they receive |
|---|---|---|
| Patient | Experimental | Not described Receives: Device: Rhinoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Frequency and severity of expected Adverse and Severe Adverse Events, as material extrusion, infection (wall abscess), and chronic pathological inflammatory reaction, pain, epistaxis.
Measured: up to 6 months after surgery
Epithelial cells affinity
macroscopic mucous membrane integrity (ciliated cells), absence of perforation, pathological analyses of biopsy to research sub epithelial infiltration, respiratory epithelial differentiation markers (HES, MOVAT pentachrome), immunohistochemistry (AB against cytokeratines 7, 8, 19, UEA1, MUC5AC) and MEB, MET analyses.
Measured: up to 6 months after surgery
Secondary outcomes (2)
Performance with Internal and external nasal shape assessment
Photography and fiberoptic endoscopy
Measured: month 2 and 6 after surgery.
Performance with Functional Performance Assessment
NOSE and RHINO quality of life questionnaires Clinical data, questionnaires, and photos will be collected pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.
Measured: pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startSep 2011
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nasal SeptumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ludovic LE TAILLANDIER de GABORY, Dr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234415
- Sponsor's protocol ID
- CHUBX 2010/16
- Other IDs
- 2010-A01133-36
- Acronym
- NASEPT
- Status last verified
- Mar 2015
- First submitted
- 2 Nov 2010
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Gabory L, Boudard P, Bessede JP, Maillard A, Lacomme S, Gontier E, Durand M, Fricain JC, Benard A, Bordenave L. Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty. Facial Plast Surg Aesthet Med. 2021 Sep;23(5):321-329. doi: 10.1089/fpsam.2020.0184. Epub 2020 Jul 16.
PubMed 32700976
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Pilot, Clinical Study of a Bone Substitute Safety and Efficacy in the Multi Traumatized Nasal Septum Reconstruction
- ClinicalTrials.gov ID
- NCT01234415
- Acronym / sponsor ID
- NASEPT / CHUBX 2010/16
- Conditions
- Nasal Septum
- Keywords
- nasal, septum, reconstruction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 4 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this project is to evaluate the safety and efficacy of the biomaterial made of HAP/TCP (BCP, Kasios®), in septoplasties of multi traumatized human nose. The use of this biomaterial will avoid the graft sampling and we expect it to be a good substitute to support the nasal pyramid while favouring the respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.
Detailed description
Five to ten percent of the post-traumatic septo-rhinoplasties require a total reconstruction of the septal skeleton. This surgery requires using autologous bone graft (iliac, costal, or parietal). However these swabs include surgical risks, have a particular morbidity non negligible and particular quality imperfections (resorption level, texture, shape, integration) requiring a complex and long lasting shaping before implantation. To avoid the using of bone graft, a large scale of products has been developed to propose a synthetic bone substitute as a support for bone reconstruction. The bone substitute, BCP, made of hydroxyl apatite (HAP) and tricalcium phosphate (TCP), is thus largely used in orthopaedics, and CE marked in numerous indications (like sinus lift). The stake is to validate that it can be used in septo-rhino-plasties. This septic zone presents characteristics which required in vitro and in vivo studies, showing that the conclusions are a good biocompatibility of BCP for human epithelial cells and in septal area of rabbits and sheep. The ultimate step to validate this concept consists in conducting a pilot clinical study on 25 patients with the indication of septoplasties to verify its safety and efficacy in clinical conditions. This study will have an 18 months inclusion period and 6 months of follow up. The principal objective is to assess the HAP/TCP biomaterial safety and to confirm clinically and histologically the good affinity of human epithelial cells for this material. Secondary objective is to demonstrate that the restoration of the normal nasal anatomy with the material re-establishes the nasal respiratory shape and function. Clinical data, questionnaires, and photos will be collected pre operatively and at day 4, 10, and month 2 and 6 after surgery. The endonasal biopsy and fiberoptic endoscopy will be realised at 2 and 6 months post operatively and will be supplementary to the routine care protocol of the surgeon.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | Experimental | Device: Rhinoplasty |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women between 18 and 60
- Indication of tissue replacement in a nasal septum, which skeleton is lacking or non usable for patients having:
- Paradoxal nasal obstruction with saddle nose type III and IV or flabby nose
- Nasal obstruction with an obstacle caused by a moved multifracture skeleton
- Written informed consent
Key exclusion criteria (13 listed)
- Post-menopausal women : lack of efficient contraception (intra uterine dispositive or contraceptive pill)
- Breast feeding or pregnant women
- HIV or VHB or VHC seropositive subject
- Inflammatory or infectious active rhino sinusitis
- Nasal an sinus surgery or trauma ended from less than 8 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RhinoplastyRhinoplasty is performed under general anaesthesia; the duration is 1 to 2 hours. The surgical approach for implantation of the biomaterial is external rhinoplasty. The incision is made at the columella (base of nose) and becomes internal for the scar to be as unobtrusive as possible. The septum skeleton is then destroyed in order to place the synthetic biomaterial. The biomaterial is remodelled in order to have a natural external aspect of the nose. The incision is closed and the wicks are put in place in the nose for 4 days. A cast and a sticker will be put in place after surgery to maintain properly the biomaterial. | Device | Patient |
Primary outcome
Safety
Time frame: up to 6 months after surgery
Frequency and severity of expected Adverse and Severe Adverse Events, as material extrusion, infection (wall abscess), and chronic pathological inflammatory reaction, pain, epistaxis.
Epithelial cells affinity
Time frame: up to 6 months after surgery
macroscopic mucous membrane integrity (ciliated cells), absence of perforation, pathological analyses of biopsy to research sub epithelial infiltration, respiratory epithelial differentiation markers (HES, MOVAT pentachrome), immunohistochemistry (AB against cytokeratines 7, 8, 19, UEA1, MUC5AC) and MEB, MET analyses.
2 secondary outcomes
Performance with Internal and external nasal shape assessment
Time frame: month 2 and 6 after surgery.
Performance with Functional Performance Assessment
Time frame: pre operatively and post operatively at day 4, 10, and month 2 and 6 after surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 32700976de Gabory L, Boudard P, Bessede JP, Maillard A, Lacomme S, Gontier E, Durand M, Fricain JC, Benard A, Bordenave L. Multicenter Pilot Study to Assess a Biphasic Calcium Phosphate Implant for Functional and Aesthetic Septorhinoplasty. Facial Plast Surg Aesthet Med. 2021 Sep;23(5):321-329. doi: 10.1089/fpsam.2020.0184. Epub 2020 Jul 16.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ludovic LE TAILLANDIER de GABORY, Dr principal investigator
University Hospital, Bordeaux
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rhinoplasty in people with Nasal Septum, run by University Hospital, Bordeaux at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: up to 6 months after surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01234415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.