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NCT Number: NCT07316101

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

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Total duration of lens-fog interruptions (minutes)

    Time frame: Before the Nasal Packing(2 hours roughly)

    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.

Secondary outcomes

  1. post-operative intracranial infection rate

    Time frame: 7 days

    Incidence of post-operative intracranial infection within 7 days (positive CSF culture OR CSF WBC ≥ 10 × 10⁶/L with fever ≥ 38.5 °C).

  2. Total irrigation fluid volume used intra-operatively (ml)

    Time frame: Before the nasal packing(2 hours roughly)

    Total irrigation fluid volume used intra-operatively (ml)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhigang Lan, M.D. PhD.

CONTACT

[email protected]

18980606446

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 5, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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