Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Anti-fog suction device-a 4 Fr multi-channel silicone catheter.
- Who it may be relevant to
- Registry conditions: Pituitary Adenoma, Craniopharyngioma. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Interventions
- Device Anti-fog suction device-a 4 Fr multi-channel silicone catheter
A single-use, sterile "anti-fog suction device" (a 4 Fr multi-channel silicone catheter) is introduced through the same nostril alongside the endoscope after induction of anaesthesia. The built-in micro-balloon is inflated with 1 ml air to anchor the tip in the posterior choana. Low-flow (2 L min-¹), filtered, room-temperature air is delivered through the central lumen, creating a gentle laminar stream that passes across the lens, continuously removing warm humid air and preventing condensatio
Primary outcome measures
- Total duration of lens-fog interruptions (minutes) [Time frame: Before the Nasal Packing(2 hours roughly)]
Secondary outcome measures (2)
- post-operative intracranial infection rate [Time frame: 7 days]
- Total irrigation fluid volume used intra-operatively (ml) [Time frame: Before the nasal packing(2 hours roughly)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
China · 1 center
- West China Hospital of Sichuan University — Chengdu
Identifiers
NCT: NCT07316101 · WestChinaH-HX-2025-06