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.
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