ClinicalTrials.gg
RecruitingNCT07316101Updated Jun 30, 2026

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

An interventional study of Anti-fog suction device-a 4 Fr multi-channel silicone catheter in Pituitary Adenoma and Craniopharyngioma, sponsored by West China Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by West China Hospital · Not applicable, Interventional, and Other

From the registry’s dates

  • Started Mar 2026; still recruiting 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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
02

Conditions studied

  • Pituitary Adenoma
  • Craniopharyngioma

Keywords

  • endoscopic endonasal surgery
  • pituitary adenoma
  • anti-fog device
  • suction irrigation
  • intracranial infection
  • randomized controlled trial
03

In context

Pituitary Neoplasms

200 studies on the registry are indexed under Pituitary Neoplasms; 51 are open to participants now.

This study's planned enrollment of 20 is below the median of 60 across 121 interventional studies indexed under Pituitary Neoplasms.

Browse Pituitary Neoplasms studies →

Lead sponsor

West China Hospital is the lead sponsor of 501 studies on the registry; 246 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • I-III
  • Able and willing to give written and comply with follow-up

Exclusion criteria

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 > 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 or follow-up
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

INR, PT and aPTT (clotting tests)

Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.

Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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).

Interventions

  • DeviceAnti-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.

06

What researchers measure

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.

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

Secondary outcomes

  1. post-operative intracranial infection rate

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

    Time frame: 7 days

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

    Total irrigation fluid volume used intra-operatively (ml)

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes

Supporting information: Study protocol

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07316101
Responsible party
Zhigang Lan (Professor, West China Hospital) — Principal investigator
First posted
Jan 5, 2026
Start date
Mar 1, 2026
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jun 30, 2026

Study contacts

Zhigang Lan, M.D. PhD.
Contact
dr.lanzhigang@wchscu.edu.cn
18980606446

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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