Anti-fog suction device during nose-route surgery for pituitary adenoma or craniopharyngioma

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with a pituitary adenoma or craniopharyngioma who are planned for surgery through the nose with an endoscope. It tests a device that keeps the camera lens from fogging.

Age

18 to 75 years

Sex

All sexes

Disease stage

Pituitary adenoma or craniopharyngioma of ≤ 3 cm (1.2 in) on MRI/CT, without extensive spread into the skull base. Planned elective endoscopic endonasal transsphenoidal surgery. General health ASA class I-III.

Earlier treatment

People whose earlier nose surgery prevents placing the device cannot join.

Main reasons for not taking part

• Severe nose deformity, polyps or earlier nose surgery that prevents placing the device
• Active nose or body-wide infection (WBC > 10 × 10⁹/L, CRP ≥ 10 mg/L), known brain infection or ongoing CSF (brain fluid) leak
• Blood clotting problems (PT > 14 s or APTT > 45 s) or blood thinners that cannot be stopped for ≥ 7 days
• Allergy to silicone or medical-grade plastics, or a planned combined approach through the skull or eye socket
• Pregnancy or breastfeeding, or a mental or cognitive disorder that prevents consent or follow-up

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 75 years old?YesNo

What the trial wants to find out

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 2 groups in the trial

• Intervention groupTreatment being tested

  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.

  Treatment: Anti-fog suction device-a 4 Fr multi-channel silicone catheter

• Control groupNo study treatment, for comparison

  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).