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NCT01824706: CUSTOMBONE
Prospective, Multicenter Observational Study Evaluating the Long Term Safety of the Custombone Implant
trial testing craniectomy in Surgery in 110 participants. Completed in 1 May 2016.
1 May 2016
Quick facts
| Lead sponsor | Integra LifeSciences Corporation |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 110 |
| Start date | 1 December 2012 |
| Primary completion | 1 May 2016 |
| Estimated completion | 1 May 2016 |
| Sites | 18 locations across France |
Drugs / interventions tested
- craniectomy
Conditions studied
- Surgery — all drugs for Surgery →
Sponsor
Integra LifeSciences Corporation — full company profile →
Who can join
Eligibility, any sex, with Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
A Prospective, Multicenter Observational Study Evaluating the Long Term Safety in Terms of Explantation Rate and Number of Infections of the Custom-made Bioceramic Implant CustomBone™ The patients will be included as soon as they are implanted and follow-up for 2 years. It is observational so no specific exam is planned. The explantation rate will be measured, that is to say the number of patients whose prosthesis will be removed (with or without any relationship with the implant or the procedure).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01824706
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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Other Integra LifeSciences Corporation trials
Trials by the same sponsor.
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- NCT06629506 — MicroMatrix® Flex in Tunneling Wounds · NA · completed
- NCT06453187 — A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers · NA · enrolling by invitation
- NCT06276543 — Bactiseal Catheter Safety Registry Study · recruiting
- NCT06297187 — Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01824706 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Integra LifeSciences Corporation
- Last refreshed: 2 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01824706.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing