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NCT03812159
Clinical Feasibility Study of Preoperative Surgical Planning
NA trial testing iCSPlan in Craniosynostoses. Withdrawn.
20 March 2024
Quick facts
| Lead sponsor | Gary F. Rogers, MD |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | supportive care |
| Start date | 1 January 2020 |
| Primary completion | 20 March 2024 |
| Estimated completion | 20 April 2024 |
| Sites | 1 location across United States |
Drugs / interventions tested
- iCSPlan
Conditions studied
- Craniosynostoses — all drugs for Craniosynostoses →
Sponsor
Gary F. Rogers, MD
Who can join
Under 18, any sex, with Craniosynostoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Most children diagnosed with craniosynostosis undergo a relatively extensive cranial vault remodeling procedure. The decision of performing surgical cranial shape correction for patients with craniosynostosis typically rests on a subjective visual assessment of the severity of the cranial malformation and the main goal of this procedure is to reduce the risk of elevated intracranial pressure and to provide a more normal cranial shape and volume. Personalized surgical planning systems to optimize intervention and leverage surgical expertise in the reconstruction of the cranial vault do not exist. Thus, the expertise of the surgeon is paramount for the success of the surgical correction of craniosynostosis. The goal of our project is to evaluate the feasibility and utility of a surgical plan derived from software developed at Children's National, iCSPlan.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT03812159
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Craniosynostoses
Currently open trials in the same condition.
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- NCT04159675 — Burosumab and 1-25 (OH) Vitamin D on Human Osteoblasts · recruiting
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 NCT03812159 (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 Gary F. Rogers, MD
- Last refreshed: 8 February 2024
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/NCT03812159.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing