Pituitary TumorNCT06472505
Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage
A study testing polyglycolic acid(Neoveil) in people with Pituitary Tumor and Cerebrospinal Fluid Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Pituitary Tumor, Cerebrospinal Fluid Leakage
- What is being tested?
- polyglycolic acid(Neoveil)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Inclusion criteria
- Patients with primary or recurrent pituitary tumors require endoscopic nasal surgery.
- Exclusion criteria
- Patients with pituitary gland tumors who do not receive surgical treatment.
- Patients with other brain tumors.
- Patients allergic to polyglycolic acid (PGA).
- Patients who have had previous radiation therapy or chemotherapy.
Trial locations and contacts
1 site in 1 country.
Abel Huang, MD contact
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, 100
Abel Huang, MD, +8860223123456 ext. 265913, how.how0622@gmail.com
About this study
Official title: Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery
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.
Read the detailed description
Neoveil, the main component, is polyglycolic acid (PGA), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. In the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. In the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. At present, the United States, Europe, Australia, China and South Korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of Neurosurgery in foreign countries. It can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. There is a license from the TFDA. In clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (Sheet) In the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation The complication rate .
- Conditions
- Pituitary Tumor, Cerebrospinal Fluid Leakage
- Being tested
- polyglycolic acid(Neoveil)
- Keywords
- Pituitary tumor, Endoscopic transnasal transsphenoidal, CSF leakage
- Medical subject headings
- Pituitary Neoplasms, Cerebrospinal Fluid Leak, Cerebrospinal Fluid Rhinorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
polyglycolic acid(Neoveil)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Using polyglycolic acid mesh | Experimental | Not described Receives: Device: polyglycolic acid(Neoveil) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesurement CSF leakage grade change after surgery
Confirmation of change in CSF leakage grafe after surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2024
- Study start1 Dec 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pituitary TumorStudies of the same condition, open and under way.
- More trials run by National Taiwan University 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abel Huang, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06472505
- Sponsor's protocol ID
- 202011030DIPB
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2022
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Polyglycolic Acid Mesh Prevents Cerebrospinal Fluid Leakage: Clinical Application to Endoscopic Endonasal Transsphenoidal Surgery
- ClinicalTrials.gov ID
- NCT06472505
- Acronym / sponsor ID
- 202011030DIPB
- Conditions
- Pituitary Tumor, Cerebrospinal Fluid Leakage
- Keywords
- Pituitary tumor, Endoscopic transnasal transsphenoidal, CSF leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 25 Jun 2024 (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 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.
Detailed description
Neoveil, the main component, is polyglycolic acid (PGA), which is a kind of absorbable material, and is made into a soft and tension non-woven material by special processing with good tissue compatibility and degradability. In the human body, its strength will gradually decrease due to hydrolysis, and will eventually be absorbed and metabolized. In the process of absorption, at first its strength is reduced, then the mass will gradually decrease, and it will be completely absorbed after about 15 weeks. At present, the United States, Europe, Australia, China and South Korea have been marketed, it is applied to the spine , pituitary tumors , skull base tumors and aneurysm surgery,etc. inthe related field of Neurosurgery in foreign countries. It can prevent the leakage of cerebrospinal fluid, and reduce the postoperative hospital stay and the probability of complications after surgery. There is a license from the TFDA. In clinical, it can be used in the sutures of parts or fragile organs that do not need to be healed for a long time, such as the lung, liver, and digestive tract, by suture (thick slice and tube type) or adhesion (Sheet) In the tissue, it can strengthen the compressive ability of the local tissue, prevent the suture thread from splitting the suture tissue, prevent the lung tissue from leaking, reduce the blood and fluid leakage from the surgical site, and reduce the postoperative hospital stay and after the operation The complication rate .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Using polyglycolic acid mesh | Experimental | Device: polyglycolic acid(Neoveil) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| 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. | Device | Using polyglycolic acid mesh |
Primary outcome
Mesurement CSF leakage grade change after surgery
Time frame: 6 months
Confirmation of change in CSF leakage grafe after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2024.
Related trials for Pituitary Tumor
RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
RecruitingObservational study
Adrenal Diseases in the Population of Modena: A Clinical-Epidemiological Database of Patients Referred to the Adrenal Disorders Outpatient Clinic of the Clinical Unit of Endocrinology at the Modena University Hospital (AOU Modena)
Cushing s Syndrome, Cushing Disease
Active, not recruitingPhase 2
Extension Study to Evaluate the Safety of Long-Term Use of Relacorilant in Patients With Cushing Syndrome
Cushing Syndrome
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Cushing Disease, Pituitary Adenoma
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. This study is not recruiting at the moment.
Abel Huang, MD contact
Abel Huang, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing polyglycolic acid(Neoveil) in people with Pituitary Tumor and Cerebrospinal Fluid Leakage, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 25 Jun 2024. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Abel Huang, MD (+8860223123456 ext. 265913, how.how0622@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesurement CSF leakage grade change after surgery (time frame: 6 months). 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 25 Jun 2024.