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

NCT07316101 | Not Yet Recruiting DMC

• 1 other identifier: WestChinaH-HX-2025-06
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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

Keywords

endoscopic endonasal surgery; pituitary adenoma; anti-fog device; suction irrigation; intracranial infection; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Total duration of lens-fog interruptions (minutes)

  defined as the cumulative time from the moment the surgeon declares "lens fogged" until clear operative view is restored, measured with a stop-watch by the circulating nurse throughout the entire endoscopic endonasal procedure.

  Before the Nasal Packing(2 hours roughly)

Secondary Outcomes (2)

• post-operative intracranial infection rate

  7 days

• Total irrigation fluid volume used intra-operatively (ml)

  Before the nasal packing(2 hours roughly)

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

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

Control group

NO INTERVENTION

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).

Interventions

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

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Pituitary Neoplasms; Craniopharyngioma

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypothalamic Diseases; Pituitary Diseases; Endocrine System Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Nerve Tissue

Central Study Contacts

Zhigang Lan, M.D. PhD.

CONTACT

18980606446; dr.lanzhigang@wchscu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 5, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL