CSF LeakCSFNCT07368348
Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
A study testing Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks in people with CSF Leak, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CSF Leak
- What is being tested?
- Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2026to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: 1- Adults (≥18 years). 2- Patients with bilateral CSF leaks confirmed by imaging and biochemical testing (e.g., beta-2 transferrin).
3- Patients with bilateral CSF leak and sever septal spur. 4- Patients with bilateral CSF leak and history of submucosal resection of nasal septum.
5- Patients with bilateral CSF leak and large septal perforation. 6- Patients with bilateral CSF Leak and septal granuloma.
Exclusion Criteria: 1- Patients with contraindications to endoscopic surgery. 2- Active sinus or nasal infections. 3- Previous nasal or skull base surgery affecting the repair site.
-
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Kafrelsheikh Faculty of Medicine
Kafr Elsheikh, Kafrelsheikh, 33155.
Amr Maher Shady, resident, 0473109517, amrshady00@gmail.com
Saad Elzayat Kafr Elsheikh Hospital University, professor, saad_hilmy@med.kfs.edu.eg
About this study
The study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
Research question:
Does the use of an internal nasal splint to support a free graft during endoscopic repair of bilateral CSF leaks improve outcomes compared to the use of a nasoseptal flap alone?
Read the detailed description
Cerebrospinal fluid (CSF) leaks are classified as traumatic, iatrogenic, or spontaneous/idiopathic. Traumatic causes include blunt or penetrating facial injuries, while iatrogenic causes stem from neurosurgical or otolaryngologic procedures, such as Functional Endoscopic Sinus Surgery (FESS).
Spontaneous CSF leaks, often linked to elevated intracranial pressure (ICP), may occur in conditions like Idiopathic Intracranial Hypertension (IIH) or due to congenital skull base defects and tumors [2]. Risk factors for spontaneous leaks include obesity, female gender, and obstructive sleep apnea, with studies showing 72% of affected patients are female and 45% have sleep apnea.
Benign Intracranial Hypertension (BIH), also known as IIH or Pseudotumor Cerebri (PTC), involves increased brain pressure without structural abnormalities and normal CSF content. Spontaneous CSF rhinorrhea, increasingly prevalent (14-55%), often requires thorough investigations (e.g., fundus examination, CT/MRI, neurological consultation) to exclude intracranial hypertension before endoscopic repair.
Lumbar drain with CSF manometry is reserved for recurrent cases, often due to benign CSF tension increases despite normal preoperative findings. Successful repair requires competent flaps/grafts to withstand CSF pressure during healing. Recurrence necessitates further investigations and may require additional CSF diversion or shunting.
Key steps for successful repair include:
- Identifying the defect(s).
- Creating a raw area around the defect by removing mucosa.
- Precisely placing a graft or flap, optionally sealing dural tears with fat or fascia.
- Applying adequate pressure to counteract CSF pressure.
Sealing mechanisms involve:
- Tucking a graft or fat under bony edges or into dural tears, though this may risk dural trauma.
- Applying a free graft or vascularized flap over the defect and surrounding bone, requiring pressure equal to or greater than CSF pressure. Combining both mechanisms with adequate pressure optimizes sealing and compensates for potential weaknesses.
From a physical perspective, grafts or flaps must exert force equal to or greater than CSF pressure to prevent leaks. On-lay grafts require sufficient force, while under-lay grafts, though challenging, benefit from additional on-lay grafts or flaps to address unnoticed defects.
Nasoseptal flaps (NSFs) have become a widely used technique for endoscopic skull base repair, particularly for cerebrospinal fluid (CSF) leaks. They are vascularized pedicled flaps that provide a robust and reliable option for sealing skull base defects. Studies have shown that NSFs have high success rates, ranging from 90% to 95%, in preventing CSF leaks postoperatively. The vascularity of the flap promotes healing and reduces the risk of graft failure, making it a preferred choice for large or complex defect.
However, NSFs are not without limitations. The technique requires a relatively intact nasal septum, which may not be feasible in patients with prior septal surgery, large septal perforations, or severe septal deformities. Additionally, harvesting the flap can lead to complications such as nasal crusting, septal perforation, and nasal obstruction, which can affect patient quality of life.
Free grafts, such as fascia lata, fat, or synthetic dural substitutes, are another option for skull base repair. These grafts are non-vascularized and rely on the surrounding tissue for nourishment. Free grafts are simpler to harvest and place, making them a viable option in cases where NSFs are not feasible. However, their success rates are generally lower than those of NSFs, with reported success rates ranging from 70% to 85%.
The main challenge with free grafts is their susceptibility to displacement and failure due to the pressure exerted by CSF. Without adequate support, free grafts may not adhere properly to the defect, leading to recurrent leaks. Techniques to improve the stability of free grafts, such as the use of fibrin glue or additional support materials, have been explored, but these methods have not consistently improved outcomes.
The study aims to evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic CSF leak repair.
- Conditions
- CSF Leak
- Being tested
- Internal Nasal Splint-Supported Free Graft, Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Keywords
- CSF, Stent
- Medical subject headings
- Cerebrospinal Fluid Otorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internal Nasal Splint-Supported Free GraftDevice
Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid LeaksDevice
Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
| Study group | Role | What they receive |
|---|---|---|
| Nasoseptal Flap for Endoscopic Skull | Experimental | • Group A: Free graft + Internal nasal splint
* Free graft material (e.g., fascia lata, fat, synthetic dural substitute) placed over the defect.
* Internal nasal splint applied to support the graft and maintain its position Receives: Device: Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks |
| Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic Skul | Experimental | • Group B: Nasoseptal flap alone.
- Standard nasoseptal flap technique used for skull base repair. Receives: Device: Internal Nasal Splint-Supported Free Graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- Primary Objective:
- To evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic repair of bilateral CSF leaks.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start1 Feb 2026
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CSF LeakStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mahr Shady, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368348
- Sponsor's protocol ID
- KFSIRB200-695
- Acronym
- CSF
- Status last verified
- Sep 2025
- First submitted
- 25 Dec 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anyone who is interestd in this study.
Publications
1- Zhang S.N., Jiang Y., Yu L.G., Zhao L.J., Li L.L., Zhang C.Y., Xu W.R., Li N. (2019). Clinical analysis of transnasal endoscopic repair of cerebrospinal fluid rhinorrhea. Lin. Chung Er. Bi Yan Hou Tou Jing Wai Ke Za Zhi, 33(12): 1189-95. doi: 10.13201/j.issn.1001-1781.2019.12.018. 2- Kim-Orden N., Shen J., Or M., Hur K., Zada G., Wrobel B. (2019). Endoscopic endonasal repair of spontaneous cerebrospinal fluid leaks using multilayer composite graft and vascularized pedicled nasoseptal flap technique. Allergy Rhinol (Providence), 10: 2152656719888622. doi: 10.1177/2152656719888622.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Internal Nasal Splint-Supported Free Graft Versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
- ClinicalTrials.gov ID
- NCT07368348
- Acronym / sponsor ID
- CSF / KFSIRB200-695
- Conditions
- CSF Leak
- Keywords
- CSF, Stent
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 26 Jan 2026 (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 study aims to compare the feasibility and effectiveness of using an internal nasal splint- supported free graft versus a nasoseptal flap alone for endoscopic repair of bilateral CSF leaks.
Research question:
Does the use of an internal nasal splint to support a free graft during endoscopic repair of bilateral CSF leaks improve outcomes compared to the use of a nasoseptal flap alone?
Detailed description
Cerebrospinal fluid (CSF) leaks are classified as traumatic, iatrogenic, or spontaneous/idiopathic. Traumatic causes include blunt or penetrating facial injuries, while iatrogenic causes stem from neurosurgical or otolaryngologic procedures, such as Functional Endoscopic Sinus Surgery (FESS).
Spontaneous CSF leaks, often linked to elevated intracranial pressure (ICP), may occur in conditions like Idiopathic Intracranial Hypertension (IIH) or due to congenital skull base defects and tumors [2]. Risk factors for spontaneous leaks include obesity, female gender, and obstructive sleep apnea, with studies showing 72% of affected patients are female and 45% have sleep apnea.
Benign Intracranial Hypertension (BIH), also known as IIH or Pseudotumor Cerebri (PTC), involves increased brain pressure without structural abnormalities and normal CSF content. Spontaneous CSF rhinorrhea, increasingly prevalent (14-55%), often requires thorough investigations (e.g., fundus examination, CT/MRI, neurological consultation) to exclude intracranial hypertension before endoscopic repair.
Lumbar drain with CSF manometry is reserved for recurrent cases, often due to benign CSF tension increases despite normal preoperative findings. Successful repair requires competent flaps/grafts to withstand CSF pressure during healing. Recurrence necessitates further investigations and may require additional CSF diversion or shunting.
Key steps for successful repair include:
- Identifying the defect(s).
- Creating a raw area around the defect by removing mucosa.
- Precisely placing a graft or flap, optionally sealing dural tears with fat or fascia.
- Applying adequate pressure to counteract CSF pressure.
Sealing mechanisms involve:
- Tucking a graft or fat under bony edges or into dural tears, though this may risk dural trauma.
- Applying a free graft or vascularized flap over the defect and surrounding bone, requiring pressure equal to or greater than CSF pressure. Combining both mechanisms with adequate pressure optimizes sealing and compensates for potential weaknesses.
From a physical perspective, grafts or flaps must exert force equal to or greater than CSF pressure to prevent leaks. On-lay grafts require sufficient force, while under-lay grafts, though challenging, benefit from additional on-lay grafts or flaps to address unnoticed defects.
Nasoseptal flaps (NSFs) have become a widely used technique for endoscopic skull base repair, particularly for cerebrospinal fluid (CSF) leaks. They are vascularized pedicled flaps that provide a robust and reliable option for sealing skull base defects. Studies have shown that NSFs have high success rates, ranging from 90% to 95%, in preventing CSF leaks postoperatively. The vascularity of the flap promotes healing and reduces the risk of graft failure, making it a preferred choice for large or complex defect.
However, NSFs are not without limitations. The technique requires a relatively intact nasal septum, which may not be feasible in patients with prior septal surgery, large septal perforations, or severe septal deformities. Additionally, harvesting the flap can lead to complications such as nasal crusting, septal perforation, and nasal obstruction, which can affect patient quality of life.
Free grafts, such as fascia lata, fat, or synthetic dural substitutes, are another option for skull base repair. These grafts are non-vascularized and rely on the surrounding tissue for nourishment. Free grafts are simpler to harvest and place, making them a viable option in cases where NSFs are not feasible. However, their success rates are generally lower than those of NSFs, with reported success rates ranging from 70% to 85%.
The main challenge with free grafts is their susceptibility to displacement and failure due to the pressure exerted by CSF. Without adequate support, free grafts may not adhere properly to the defect, leading to recurrent leaks. Techniques to improve the stability of free grafts, such as the use of fibrin glue or additional support materials, have been explored, but these methods have not consistently improved outcomes.
The study aims to evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic CSF leak repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasoseptal Flap for Endoscopic Skull | Experimental | Device: Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks• Group A: Free graft + Internal nasal splint * Free graft material (e.g., fascia lata, fat, synthetic dural substitute) placed over the defect. * Internal nasal splint applied to support the graft and maintain its position |
| Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic Skul | Experimental | Device: Internal Nasal Splint-Supported Free Graft• Group B: Nasoseptal flap alone. - Standard nasoseptal flap technique used for skull base repair. |
Who may qualify
- Ages
- 18 to 70 years
- 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 |
|---|---|---|
| Internal Nasal Splint-Supported Free GraftEvaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks | Device | Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic Skul |
| Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid LeaksNasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks | Device | Nasoseptal Flap for Endoscopic Skull |
Primary outcome
Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks
Time frame: baseline
• Primary Objective: - To evaluate the effectiveness of internal nasal splints in improving the feasibility and success rate of free grafts during endoscopic repair of bilateral CSF leaks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Results publication1- Zhang S.N., Jiang Y., Yu L.G., Zhao L.J., Li L.L., Zhang C.Y., Xu W.R., Li N. (2019). Clinical analysis of transnasal endoscopic repair of cerebrospinal fluid rhinorrhea. Lin. Chung Er. Bi Yan Hou Tou Jing Wai Ke Za Zhi, 33(12): 1189-95. doi: 10.13201/j.issn.1001-1781.2019.12.018. 2- Kim-Orden N., Shen J., Or M., Hur K., Zada G., Wrobel B. (2019). Endoscopic endonasal repair of spontaneous cerebrospinal fluid leaks using multilayer composite graft and vascularized pedicled nasoseptal flap technique. Allergy Rhinol (Providence), 10: 2152656719888622. doi: 10.1177/2152656719888622.
- Individual participant dataSharing planned: Undecided. anyone who is interestd in this study.
Related trials for CSF Leak
Not yet recruiting
A Prospective, Randomized, Two-Arm, Controlled, Single-Blind, Multi-Center Study to Evaluate the Safety and Efficacy of ArtiFix® Dural Repair Sealant Graft in Cranial and Spine Surgery (NEOFIX Study)
CerebroSpinal Fluid (CSF) Leak, Dural Tear
Recruiting
Role of Novel RADA16 Hydrogel in Endoscopic Skull Base Surgery
Skull Base Neoplasms, Cerebrospinal Fluid Leakage
RecruitingObservational study
Immiseal™ Dural Sealant Post-Market Registry Study
Dural Defect, Cerebrospinal Fluid Leak
Recruiting
Conservative vs Interventional Management of Postsurgical CSF Pseudomeningocele
CSF Leak, CSF Pressure Increased
RecruitingObservational study
Analysis of Cerebrospinal Fluid Leakage After Surgery for Intracranial Tumors
Brain Tumor Adult, Brain Tumor Benign
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internal Nasal Splint-Supported Free Graft and Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks in people with CSF Leak, run by Kafrelsheikh University at 1 site in Egypt.
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: looking for participants now, as of the sponsor's last update on 27 May 2026. 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Maher Shady, resident (0473109517, amrshady00@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Internal Nasal Splint-Supported Free Graft versus Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07368348, which also lists 1 linked publication.
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 27 May 2026.