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

NCT07316101 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-01-05

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2026-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07316101 on ClinicalTrials.gov