RecruitingNot ApplicableNCT06472505

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery


Sponsor

National Taiwan University Hospital

Enrollment

30 participants

Start Date

Dec 1, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The papers propose a new method to prevent postoperative cerebrospinal fluid leakage. Doctors use the absorbable polyglycolic acid (PGA) and fibrin glue to repair in surgery, prevent cerebrospinal fluid leakage and reduce the necessity of postoperative lumbar drainage after surgery. This study will analyze the changes in cerebrospinal fluid leakage in patients with pituitary tumors and skull base tumors after surgery, and further understand the effectiveness of Neoveil , as the basis for the development of new treatments.


Eligibility

Min Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a special mesh material (polyglycolic acid) can prevent spinal fluid leaks after surgery through the nose to remove a pituitary tumor — a small gland at the base of the brain. Researchers want to know if placing this mesh during surgery helps seal the area and reduce complications. **You may be eligible if...** - You have a pituitary gland tumor (either a first-time diagnosis or a returning tumor) - You are scheduled for endoscopic nasal surgery (surgery through the nose) to remove it **You may NOT be eligible if...** - Your pituitary tumor is not being treated with surgery - You have another type of brain tumor (not pituitary) - You are allergic to polyglycolic acid - You have previously had radiation therapy or chemotherapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEpolyglycolic acid(Neoveil)

This study plans to enroll patients with pituitary tumors who need to undergo surgical treatment according to current routine medical standards. After the tumor tissue is removed, the integrity of the spider web or skull base will be thoroughly checked by endoscopy during the operation to confirm whether there is any cerebrospinal fluid leakage. At the end of the operation, use a 100\*50\*0.15mm, green sheet-like Navi tissue repair patch, cut it aseptically to fit the size of the defect for repair (the common case is 2\*3.5cm defect), and place it on the spider web or skull base Tissue repair at the surgical site to prevent cerebrospinal fluid leakage.


Locations(1)

National Taiwan University Hospital

Taipei, Taiwan

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NCT06472505


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