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

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

Recruiting
18-75 years
All
Phase N/A

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Overview

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

Eligibility

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 details
    Pituitary Adenoma
    Craniopharyngioma

NCT07316101

West China Hospital

4 July 2026

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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