Anti-fog suction device during endoscopic pituitary surgery
Official title: Clinical Trial of an Anti-Fog Drainage Device for Endoscopic Endonasal Sellar Region Tumor Surgery
Run by West China Hospital · NCT07316101 · Data updated 2026-11-12
This trial tests whether an anti-fog suction device helps keep the view clear during pituitary tumor surgery and whether it lowers brain-fluid infection risk compared with the usual water-squirting method.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | West China Hospital Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07316101 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-75 with a preoperative diagnosis of pituitary adenoma or craniopharyngioma (≤3 cm) scheduled for elective endoscopic endonasal resection and without major nasal or systemic contraindications.
✕Probably not a fit
Patients with severe nasal structural issues, active nasal infection, intracranial infection, or other exclusion criteria may not benefit from the device.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares an anti-fog suction device to the standard water-squirting method during endoscopic endonasal pituitary surgery for pituitary adenoma or craniopharyngioma. It aims to see if the device reduces lens fogging and surgical pauses, and what safety issues may arise, including nosebleeds, tube blockage, or infection. Participants will be randomly assigned to receive either the device or the conventional method during their planned surgery and will be monitored during hospitalization with follow-ups around day 7. Operating times, fog-related interruptions, and laboratory results will be recorded to assess performance and safety. The study will also collect standard postoperative recovery data to evaluate overall safety and feasibility.
Why it matters
Potential benefit: If successful, the device could shorten surgery time and reduce fog-related interruptions, potentially improving safety and efficiency of pituitary tumor surgeries.
How similar studies have gone: Prior methods for reducing fog have been variable; this study tests a dedicated anti-fog device in a specific surgical context, with limited prior direct evidence.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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West China Hospital of Sichuan University
Chengdu, Sichuan, China Recruiting
Study contacts
- Study coordinator: Zhigang Lan, M.D. PhD.
- Email: dr.lanzhigang@wchscu.edu.cn
- Phone: 18980606446
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.