Last reviewed · How we verify

NCT03812159

Clinical Feasibility Study of Preoperative Surgical Planning

Withdrawn NA Last updated 8 February 2024
What this trial tests

NA trial testing iCSPlan in Craniosynostoses. Withdrawn.

Timeline
1 January 2020
Primary endpoint
20 March 2024
20 April 2024

Quick facts

Lead sponsorGary F. Rogers, MD
PhaseNA
StatusWithdrawn
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Start date1 January 2020
Primary completion20 March 2024
Estimated completion20 April 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

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:

Other recruiting trials for Craniosynostoses

Currently open trials in the same condition.

Verify against primary sources

Data sources for this page

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