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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
China
West China Hospital of Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Zhigang Lan, M.D. PhD.
dr.lanzhigang@wchscu.edu.cn
18980606446
Time Frame
Start Date: 2026-03-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 20
Treatments
Experimental: Intervention group
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 condensation.~Two side ports provide continuous low-pressure (-5 cmH₂O) suction of any blood or fluid, keeping the surgical field dry.~The device remains in place for the entire operation and is removed before nasal packing. No extra incisions or sutures are required.
No_intervention: Control group
Standard care: whenever the lens fogs, the scrub nurse withdraws the endoscope and irrigates its tip with 5-10 ml of 37 °C sterile saline from a 20 ml syringe. This manoeuvre is repeated as often as necessary (average 10-15 times per case).
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov