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

Recruiting now · Not applicable

Conditions studied: Pituitary Adenoma, Craniopharyngioma

In brief

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 to record operating times, any fog-related pauses, and results of blood or spinal-fluid tests taken before and after surgery

Key facts

Study ID

NCT07316101

Run by

West China Hospital

People needed

20

Starts

2026-03-01

Expected to finish

2026-12-31

Last updated by the study team

2026-06-30

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• West China Hospital of Sichuan University — Chengdu, Sichuan, China (enrolling)

Full record on ClinicalTrials.gov

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