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RECRUITINGINTERVENTIONAL

Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

A. Inclusion criteria 1\. Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery. B. Exclusion criteria 1. Patients with pituitary gland tumors who do not receive surgical treatment. 2. Patients with other brain tumors. 3. Patients allergic to polyglycolic acid (PGA). 4. Patients who have had previous radiation therapy or chemotherapy. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
A. Inclusion criteria 1\. Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery. B. Exclusion criteria 1. Patients with pituitary gland tumors who do not receive surgical treatment. 2. Patients with other brain tumors. 3. Patients allergic to polyglycolic acid (PGA). 4. Patients who have had previous radiation therapy or chemotherapy.

Treatments Being Tested

DEVICE

polyglycolic 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