NCT07368348

Brief 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. 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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
6mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress35%
Feb 2026Nov 2026

First Submitted

Initial submission to the registry

December 25, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 26, 2026

Completed
6 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 26, 2026

Status Verified

September 1, 2025

Enrollment Period

4 months

First QC Date

December 25, 2025

Last Update Submit

January 18, 2026

Conditions

CSF Leak

Keywords

CSF, Stent

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline

Study Arms (2)

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

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.

Device: Internal Nasal Splint-Supported Free Graft

Interventions

Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid LeaksDEVICE

Nasoseptal Flap for Endoscopic Skull Base Repair in Cerebrospinal Fluid Leaks

Nasoseptal Flap for Endoscopic Skull
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

Evaluation of Internal Nasal Splint-Supported Free Graft in Endoscopic Skul

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with bilateral CSF leak and sever septal spur. 4- Patients with bilateral CSF leak and history of submucosal resection of nasal septum.
  • Patients with bilateral CSF leak and large septal perforation. 6- Patients with bilateral CSF Leak and septal granuloma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kafrelsheikh Faculty of Medicine

Kafr Elsheikh, Kafrelsheikh, 33155., Egypt

RECRUITING

Related Publications (1)

  • Kim-Orden N, Shen J, Or M, Hur K, Zada G, Wrobel B. Endoscopic Endonasal Repair of Spontaneous Cerebrospinal Fluid Leaks Using Multilayer Composite Graft and Vascularized Pedicled Nasoseptal Flap Technique. Allergy Rhinol (Providence). 2019 Nov 13;10:2152656719888622. doi: 10.1177/2152656719888622. eCollection 2019 Jan-Dec.

    PMID: 31763054RESULT

MeSH Terms

Conditions

Cerebrospinal Fluid Otorrhea

Condition Hierarchy (Ancestors)

Cerebrospinal Fluid LeakNeurologic ManifestationsNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Central Study Contacts

Amr Maher Shady, resident

CONTACT

0473109517amrshady00@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident

Study Record Dates

First Submitted

December 25, 2025

First Posted

January 26, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 26, 2026

Record last verified: 2025-09

Locations

EG(1)