Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction (NCT01234415) | Clinical Trial Compass
CompletedPhase 2
Bone Substitute in the Multi Traumatized Nasal Septum Reconstruction
France26 participantsStarted 2011-09
Plain-language 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 respiratory epithelium regeneration. Thus, that would confirm previous in vitro and in vivo studies.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.