Pituitary AdenomaNCT07316101
Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
A study testing Anti-fog suction device-a 4 Fr multi-channel silicone catheter in people with Pituitary Adenoma and Craniopharyngioma, run by West China Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pituitary Adenoma, Craniopharyngioma
- What is being tested?
- Anti-fog suction device-a 4 Fr multi-channel silicone catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Zhigang Lan, M.D. PhD., 18980606446, 158075478@qq.com
158075478@qq.com
About this study
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:
Read more
- 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
- Pituitary Adenoma, Craniopharyngioma
- Being tested
- Anti-fog suction device-a 4 Fr multi-channel silicone catheter
- Keywords
- endoscopic endonasal surgery, pituitary adenoma, anti-fog device, suction irrigation, intracranial infection, randomized controlled trial
- Medical subject headings
- Pituitary Neoplasms, Craniopharyngioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-fog suction device-a 4 Fr multi-channel silicone catheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Device: Anti-fog suction device-a 4 Fr multi-channel silicone catheter |
| Control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before the Nasal Packing(2 hours roughly)
Secondary outcomes (2)
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).
Measured: 7 days
Total irrigation fluid volume used intra-operatively (ml)
Total irrigation fluid volume used intra-operatively (ml)
Measured: Before the nasal packing(2 hours roughly)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary AdenomaStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhigang Lan, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07316101
- Sponsor's protocol ID
- WestChinaH-HX-2025-06
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes