NCT07539792 Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
| NCT ID | NCT07539792 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Nanfang Hospital, Southern Medical University |
| Condition | Sellar Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2026-04-01 |
| Primary Completion | 2029-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 126 participants in total. It began in 2026-04-01 with a primary completion date of 2029-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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 discussion; 4. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months; 5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range; 6. Sign the informed consent form and are willing to participate in the study. Exclusion Criteria: 1. Patients with other concurrent intracranial tumors or severe brain lesions; 2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery; 3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases; 4. Pregnant or lactating women; 5. Patients who have previously received radiotherapy or chemotherapy; 6. Patients with active nasal infections, inflammation, or severe nasal diseases; 7. Patients with a history of severe allergies to drugs or synthetic materials; 8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery; 9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07539792 clinical trial?
This trial is open to participants of all sexes, aged 1 Year or older, up to 80 Years, studying Sellar Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07539792 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07539792 currently recruiting?
Yes, NCT07539792 is actively recruiting participants. Contact the research team at 1448875873@qq.com for enrollment information.
Where is the NCT07539792 trial being conducted?
This trial is being conducted at Foshan, China, Gaozhou, China, Guangzhou, China, Guangzhou, China and 4 additional locations.
Who is sponsoring the NCT07539792 clinical trial?
NCT07539792 is sponsored by Nanfang Hospital, Southern Medical University. The trial plans to enroll 126 participants.