Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended E… (NCT07539792) | Clinical Trial Compass
RecruitingPhase 2
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
China126 participantsStarted 2026-04-01
Plain-language summary
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 surgery on the incidence of intracranial infection within 1 months after surgery;
2. 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;
3. To monitor and evaluate the safety of absorbable and moldable skull base support plates, especially the occurrence of nasal complications.
Who can participate
Age range1 Year – 80 Years
SexALL
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Inclusion criteria
✓. Aged 1-80 years, regardless of gender;
✓. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data;
✓. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion;
✓. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months;
✓. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range;
✓. Sign the informed consent form and are willing to participate in the study.
Exclusion criteria
✕. Patients with other concurrent intracranial tumors or severe brain lesions;
✕. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
✕. Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
What they're measuring
1
Incidence of cerebrospinal fluid (CSF) rhinorrhea
Timeframe: Within 1 month postoperatively
Trial details
NCT IDNCT07539792
SponsorNanfang Hospital, Southern Medical University
✕. Patients who have previously received radiotherapy or chemotherapy;
✕. Patients with active nasal infections, inflammation, or severe nasal diseases;
✕. Patients with a history of severe allergies to drugs or synthetic materials;
✕. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;