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

NCT ID: NCT07316101

Last Updated: 2026-01-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2026-12-31

Brief 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

Conditions

Pituitary Adenoma; Craniopharyngioma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DEVICE

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.

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

West China Hospital

OTHER

Sponsor Role: lead

Responsible Party

Zhigang Lan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Zhigang Lan, M.D. PhD.

Role: CONTACT

dr.lanzhigang@wchscu.edu.cn

18980606446

Other Identifiers

WestChinaH-HX-2025-06

Identifier Type: -

Identifier Source: org_study_id