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Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery

RecruitingNAAges 18 Years - 75 YearsAllWest China Hospital
NCT07316101 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to learn if the anti-fog suction device works to keep the surgical view clear during endoscopic nose-to-pituitary operations and whether it lowers the chance of brain-fluid infection. It will also learn about the safety of the device. The main questions it aims to answer are: * Does the device reduce the total time the surgeon has to stop because the lens fogs up? * What medical problems (such as nose-bleed, tube blockage, or infection) do participants have when the device is used? Researchers will compare the anti-fog device to the usual "water-squirt" method to see if the device works better. Participants will: * Have either the device or the usual water method applied during their planned pituitary surgery * Stay in the hospital for the normal recovery period (about 3-5 days) and return for a routine check-up around day 7 * Allow the study team

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age 18-75 years * Pre-operative MRI/CT diagnosis of pituitary adenoma or craniopharyngioma ≤ \*3 cm without extensive skull-base invasion * Scheduled for elective endoscopic endonasal transsphenoidal resection * ASA physical status I-III * Able and willing to give written informed consent and comply with follow-up Exclusion Criteria: * Severe nasal anatomical deformity, polyps, or prior nasal surgery preventing device placement * Active nasal or systemic infection (WBC \> 10 × 10⁹/L, CRP ≥ 10 mg/L) * Known intracranial infection or ongoing CSF leak * Coagulopathy (PT \> 14 s or APTT \> 45 s) or anticoagulation that cannot be stopped ≥ 7 days * Allergy to silicone or medical-grade plastics * Planned combined transcranial or transorbital approach * Pregnancy or breastfeeding * Psychiatric or cognitive disorder precluding informed consent or follow-up
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What it tests

  • Anti-fog suction device-a 4 Fr multi-channel silicone catheter
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Where

1 site
West China Hospital of Sichuan University
Chengdu, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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