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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
- ClinicalTrials.gov ID
- NCT07316101
- Acronym / sponsor ID
- WestChinaH-HX-2025-06
- Conditions
- Pituitary Adenoma, Craniopharyngioma
- Keywords
- endoscopic endonasal surgery, pituitary adenoma, anti-fog device, suction irrigation, intracranial infection, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 5 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Anti-fog suction device-a 4 Fr multi-channel silicone catheterA 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. |
| 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-fog suction device-a 4 Fr multi-channel silicone catheterA 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 | Intervention group |
Primary outcome
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.
2 secondary outcomes
post-operative intracranial infection rate
Time frame: 7 days
Total irrigation fluid volume used intra-operatively (ml)
Time frame: Before the nasal packing(2 hours roughly)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhigang Lan, M.D. PhD. (18980606446, dr.lanzhigang@wchscu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total duration of lens-fog interruptions (minutes) (time frame: Before the Nasal Packing(2 hours roughly)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.