NIPH Clinical Trials Search

Safety and Feasibility of Using the Patient's Own Tissue Sheet for Brain Membrane Repair After Skull Base Surgery

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Patients scheduled to undergo endoscopic endonasal surgery requiring skull base dural reconstruction
Date of first enrollment	11/05/2026
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	Between 1 and 3 months prior to endoscopic endonasal tumor resection, two investigational medical devices, Bio-Sheet Makers (BSM2; Biotube Co., Ltd.), will be implanted into the abdomen under local anesthesia. These devices will be explanted under general anesthesia at the time of tumor resection to harvest sheet-like autologous collagen tissues, which will then be utilized for dural reconstruction. Furthermore, as an autologous material, this tissue will also be applied to repair nasal mucosal defects, serving as a mucosal reconstructive graft.

Outcome(s)

Primary Outcome	Feasibility of dural reconstruction using autologous collagen tissue formed by BSM2 Incidence of cerebrospinal fluid leakage within months postoperatively following dural reconstruction using BSM2-generated autologous collagen tissue
Secondary Outcome	Assessment of pain at the abdominal wound site Occurrence of adverse events Evaluation of the morphological characteristics of the formed autologous collagen tissue (major axis, minor axis, and thickness) Utility of surplus autologous collagen tissue for the closure of nasal mucosal defects Histological evaluation of surplus autologous collagen tissue

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	< 75age old
Gender	Both
Include criteria	To be eligible for inclusion in this study, patients must meet all of the following criteria: 1.Patients with a waiting period for surgery of between 1 and 3 months. 2.Patients undergoing endoscopic endonasal surgery requiring reconstruction for an extensive dural defect (as defined below) created during the procedure. 3.Patients aged 18 years or older and under 75 years at the time of informed consent. 4.Patients who have provided written informed consent of their own free will after receiving adequate explanation and demonstrating sufficient understanding of the study. [Definition of "Extensive Dural Defect"] An "extensive dural defect" is defined as a condition among Esposito grade III cases where the dural opening beyond the diaphragma sellae forms a planar defect, rather than a simple linear incision. This condition renders reliable watertight closure by fat tissue packing alone difficult, making "planar" reconstruction using sheet-like tissue (e.g., fascia lata) indispensable.
Exclude criteria	1. Poorly controlled diabetes mellitus (HbA1c [NGSP] >= 8.5%). 2. Severe renal disease (BUN >= 25 mg/dL or serum creatinine >= 2.0 mg/dL). 3. Pregnancy or suspected pregnancy. 4. Currently receiving antiplatelet or anticoagulant therapy. 5. Lactating/breastfeeding. 6. Administration of another investigational drug or product within 3 months prior to implantation of the study device. 7. Any other condition that the principal investigator or sub-investigator considers inappropriate for study participation.