NCT07539792RecruitingPhase 2
Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
Source: ClinicalTrials.gov · Last updated 20 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 13 Apr 2026
- Start date
- 1 Apr 2026
- Primary completion date
- 31 Mar 2029
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Childhood cancers
- NCT number
- NCT07539792
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 126
- From 1 Apr 2026 to the primary completion date, 31 Mar 2029
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with other concurrent intracranial tumors or severe brain lesions;
- Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery;
- Patients who have previously received radiotherapy or chemotherapy;
- Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery;
Other illness
- Patients with uncontrolled severe heart, lung, kidney, or liver diseases;
- Patients with active nasal infections, inflammation, or severe nasal diseases;
- Patients with a history of severe allergies to drugs or synthetic materials;
- Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
Other
- Pregnant or lactating women;
Who the study is looking for
- 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.
Age in the registry: 1 year to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First People's Hospital of Foshan Coordinator of this site? Confirm its status | Foshan | China | Not yet recruiting |
| Gaozhou People's Hospital Coordinator of this site? Confirm its status | Gaozhou | China | Not yet recruiting |
| Sun Yat-sen University Cancer Center Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Southern Medical University, Nanfang Hospital, Department of Neurosurgery Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
| Guangdong Provincial Hospital of Traditional Chinese Medicine Coordinator of this site? Confirm its status | Guangzhou | China | Not yet recruiting |
| Huizhou Central People's Hospital Coordinator of this site? Confirm its status | Huizhou | China | Not yet recruiting |
| Liuzhou People's Hospital Coordinator of this site? Confirm its status | Liuzhou | China | Not yet recruiting |
| The First People's Hospital of Zhaoqing Coordinator of this site? Confirm its status | Zhaoqing | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.