Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorWest China Hospital
About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Anti-fog suction device-a 4 Fr multi-channel silicone catheter
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov