New dissolving plate could stop brain fluid leaks after nose surgery
NCT ID NCT07539792
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a special plate that dissolves over time, placed during nose surgery to remove pituitary tumors. The plate supports the skull base to prevent spinal fluid leaks, a common complication. About 126 people aged 1 to 80 with sellar tumors will be randomly assigned to get the plate or standard care. The main goal is to see if the plate reduces fluid leaks within the first month after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- absorbable and moldable skull base support plate (device)
- What this could lead to
- If it works, this could reduce the risk of spinal fluid leaks and infections after pituitary tumor surgery, leading to faster recovery and shorter hospital stays.
- What could go wrong
- This is a Phase 2 trial with only 126 participants, so results may not apply to all patients. The plate is new and could cause nasal complications or fail to prevent leaks.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2026
- Expected to finish
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Feb 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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1 year to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Aged 1-80 years, regardless of gender; 2. Diagnosed with sellar region tumors confirmed by clinical symptoms, endocrine examinations, and imaging data; 3. Planned to undergo extended endoscopic endonasal transsphenoidal approach surgery as determined by departmental discussion; 4. Karnofsky Performance Status score ≥ 70, with an expected survival period ≥ 24 months; 5. Laboratory indicators (such as liver and kidney function, blood routine, etc.) within the normal range or controllable range; 6. Sign the informed consent form and are willing to participate in the study. Exclusion Criteria: 1. Patients with other concurrent intracranial tumors or severe brain lesions; 2. Patients scheduled to undergo craniotomy or non-extended endoscopic endonasal transsphenoidal surgery; 3. Patients with uncontrolled severe heart, lung, kidney, or liver diseases; 4. Pregnant or lactating women; 5. Patients who have previously received radiotherapy or chemotherapy; 6. Patients with active nasal infections, inflammation, or severe nasal diseases; 7. Patients with a history of severe allergies to drugs or synthetic materials; 8. Patients with extensive skull base bone destruction evaluated by preoperative imaging, for whom it is estimated that support materials cannot be used during surgery; 9. Patients with mental illness or cognitive impairment who are unable to complete follow-up or understand the purpose of the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Gaozhou People's Hospital
NOT_YET_RECRUITINGGaozhou, Guangdong, China
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Guangdong Provincial Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITINGGuangzhou, Guangdong, China
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Huizhou Central People's Hospital
NOT_YET_RECRUITINGHuizhou, Guangdong, China
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Liuzhou people's hospital
NOT_YET_RECRUITINGLiuzhou, Guangxi, China
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Southern Medical University, Nanfang Hospital, Department of Neurosurgery
RECRUITINGGuangzhou, Guangdong, 510515, China
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Sun Yat-sen University Cancer Center
NOT_YET_RECRUITINGGuangzhou, Guangdong, 510060, China
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The First People's Hospital Of Foshan
NOT_YET_RECRUITINGFoshan, Guangdong, China
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The First People's Hospital of Zhaoqing
NOT_YET_RECRUITINGZhaoqing, Guangdong, China
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