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Tests treatment safety and results for Sellar Tumor
Official title Efficacy and Safety Evaluation of Absorbable and Moldable Skull Base Support Plates in Extended Endoscopic Endonasal Transsphenoidal Surgery: A Prospective, Randomized, Controlled Study
ClinicalTrials.gov ID: NCT07539792
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 1 to 80
You may be able to join if
- 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;
You likely can't join if
- 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;
- Pregnant or lactating women;
- Patients who have previously received radiotherapy or chemotherapy;
- Patients with active nasal infections, inflammation, or severe nasal diseases;
See the full eligibility 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.
- 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;
- Pregnant or lactating women;
- 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;
- Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
The study team makes the final eligibility decision.
Where it's taking place
- Foshan, Guangdong, China
- Gaozhou, Guangdong, China
- Guangzhou, Guangdong, China
- Huizhou, Guangdong, China
- Zhaoqing, Guangdong, China
- Liuzhou, Guangxi, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 1 year to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Foshan, Guangdong, China; Gaozhou, Guangdong, China; Guangzhou, Guangdong, China; Huizhou, Guangdong, China; Zhaoqing, Guangdong, China; Liuzhou, Guangxi, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.