Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study

Recruiting Phase 2 Interventional Study
Sellar Tumor Endonasal Surgery Csf Leakage
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
1 – 80
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
126 (estimated)
Sponsor
Nanfang Hospital, Southern Medical University · Other
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About This Trial
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: 1. To evaluate the effect of absorbable and moldable skull base support plates used in extended endoscopic endonasal transsphenoidal…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Aged 1-80 years, regardless of gender; 2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data; 3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussio…
Contacts

Jun Pan MD, Ph.D

+86-13076878155

1448875873@qq.com

CONTACT