Patients scheduled to undergo endoscopic endonasal surgery requiring skull base dural reconstruction endoscopic endonasala surgery, skull base reconstruction
Conditions
Interventions
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
Sponsors
Kino Hiroyoshi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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.
Exclusion criteria
Exclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Contacts
Public ContactHiroyoshi Kino
University of Tsukuba Hospital
Outcome results
None listed