Phase 2 Trial of Absorbable and Moldable Skull Base Support Plates in Endoscopic Endonasal Surgery
Summary
NIH registered a Phase 2 clinical trial (NCT07539792) on April 20, 2026, to evaluate the efficacy and safety of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery for sellar tumors. The primary endpoint is the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery; secondary endpoints include intracranial infection rates, surgery duration, hospital stay length, and nasal complications. The study is a prospective, randomized, controlled trial.
What changed
This is a clinical trial registration on ClinicalTrials.gov, not a regulatory action imposing compliance obligations. The document describes a prospective, randomized, controlled Phase 2 study evaluating absorbable and moldable skull base support plates in endoscopic endonasal transsphenoidal surgery. Primary outcome measures CSF rhinorrhea incidence within 1 month post-surgery; secondary outcomes include intracranial infection, surgery duration, hospital stay, and safety monitoring. No compliance deadlines, penalties, or required actions for external parties are stated.
For compliance readers, this registration has no immediate regulatory implications. Healthcare providers and medical device manufacturers involved in skull base surgery research may find the study relevant to ongoing product development or clinical practice evidence, but no regulatory obligations arise from this registration.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Phase 2 NCT07539792 Kind: PHASE2 Apr 20, 2026
Abstract
Primary objective: To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of cerebrospinal fluid (CSF) rhinorrhea within 1 month after surgery.
Secondary objectives:
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the incidence of intracranial infection within 1 months after surgery;
- To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal surgery on the duration of the surgery and length of postoperative hospital stay;
- To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
Conditions: Sellar Tumor, Endonasal Surgery, Csf Leakage
Interventions: Absorbable and moldable skull base support plate
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