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

January 1, 2026 updated by: Zhigang Lan, West China Hospital

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the Nasal Packing(2 hours roughly)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 days
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)
Before the nasal packing(2 hours roughly)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

West China Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 18, 2025

First Submitted That Met QC Criteria

January 1, 2026

First Posted (Actual)

January 5, 2026

Study Record Updates

Last Update Posted (Actual)

January 5, 2026

Last Update Submitted That Met QC Criteria

January 1, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WestChinaH-HX-2025-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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