N/A N=105 Study of SyntheCelTM Dura Replacement to Other Dura Replacements
Cranial Dura Repair
Primary: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele — 57; 33 participants
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
N/A N=92 A Prospective, Randomized, Controlled Multi-center Study of ArtiFascia® Dural Repair Patch Compared With Commercially Available Dural Substitutes. To Evaluate the Safety and Effectiveness of ArtiFascia® in Subjects Requiring Dural Repair.
Dural Tear · Cerebrospinal Fluid Leak
Primary: Absence of Cerebrospinal Fluid Fistula (Drainage From Wound or Sinus) and Pseudo-meningocele Within 6 Months Post-operative as Evaluated by MRI Imaging. — 0; 0; 27; 58…
Phase 3 N=224 Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
Cerebrospinal Fluid Leak
Primary: Number of Participants With No CSF Leak During and After Surgery — 76; 87 Participants
Phase 3 N=250 Safety and Effectiveness of the Adherus Dural Sealant System When Used as a Dural Sealant in Cranial Procedures
Elective Cranial Procedures With Dural Incision
Primary: Proportion of Treated Subjects Who Were Free of Intra-operative Cerebrospinal Fluid (CSF) Leakage From Dural Repair During Valsalva Maneuver, CSF Leak /…
Phase 3 N=34 Duragen Versus Duraguard in Chiari Surgery
Chiari Malformation
Primary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
N/A N=98 Study to Evaluate Safety & Effectiveness of Spinal Sealant
Cerebrospinal Fluid Leakage, Subdural
Primary: Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) — 98.0; 79.2 percentage of participants
N/A N=237 DuraSeal Sealant Post Market Study
Elective Cranial Procedures With Dural Incision
Primary: Percentage of Subjects With Surgical Wound Complications, Central Nervous System Events, and Neurosurgical Complications Related to Unplanned Intervention or Return to…
Phase 3 N=234 The EVICEL® Neurosurgery Phase III Study
Cerebrospinal Fluid Leak
Primary: Primary Effectiveness Endpoint Success Number of Successes (Subjects That Had no Inter-operative CSF Leak Following Valsalva Maneuver and no CSF Leak or…
N/A N=158 Study to Evaluate Safety and Effectiveness of Spinal Sealant
Spinal Procedure Requiring Dura Incision
Primary: Watertight Dural Closure — 102; 36 Participants
Phase 2 N=75 Fibrin Sealant for the Sealing of Dura Sutures
Pathological Processes in the Posterior Fossa · Dura Defects
Primary: Incidence of Cerebrospinal Fluid (CSF) Leakage Observed After Surgery — 74.07; 78.13 percentage of participants — p=0.7159
Phase 3 N=726 TASALL - TachoSil® Against Liquor Leak
Cerebrospinal Fluid Leaks
Primary: Percentage of Participants With Clinically Evident Verified Post-Operative Cerebrospinal Fluid Leak or Clinically Evident Pseudomeningocele or Treatment Failure — 6.9…
N/A N=162 Posterior Fossa Decompression With or Without Duraplasty for Chiari Type I Malformation With Syringomyelia
Arnold-Chiari Malformation, Type 1 · Chiari Malformation Type I · Type I Arnold-Chiari Malformation
Primary: The Number of Participants With Surgical Complications — 8; 10 Participants
Phase 4 N=256 Phase IV Bioseal Study in Brain Tumor Surgery
Hemostasis · Meningioma Surgery
Primary: Hemostasis at the Target Bleeding Site (TBS) at 6 Minutes Following Treatment Application. Hemostasis is Defined as no Detectable Bleeding at the TBS. — 99.2; 100 % of…
N/A N=34 Mesh Fixation and Closure of Peritoneum Following Laparoscopic Hernia Repair Using N-butyl Cyanoacrylate
Hernia, Inguinal
Primary: Number of Participants With Safe Fixation of Mesh and Closure of Peritoneum by Clinical Investigation During Hospital Stay and Telephone Interview at Six Weeks…
N/A N=47 Nasal Septal Flap for Donor Site Reconstruction
Nasal Septum Perforation
Primary: Mean Change in Post-operative Remucosalization at the Donor Site — 47.8; 37.8; 49.7; 43.5 percentage of remucosalization
N/A N=376 Middle Meningeal Artery Embolization for the Treatment of Subdural Hematomas With TRUFILL® n-BCA
Chronic Subdural Hematoma
Primary: Residual or Re-accumulation of the Chronic Subdural Hematoma (cSDH) (Greater Than [>] 10 Millimeter [mm]) as Assessed by an Independent Core Laboratory OR Any…
N/A N=30 Study of Suture Repair of Torn Meniscus in the Knee
Meniscal Tear · Meniscus Tear
Primary: Freedom From Re-operation of the Index Meniscus Repair Site (Incidence of Subjects Requiring Re-operation) — 26; 1; 23; 2 Participants
Phase 2 N=15 A Randomized Trial of CT Fluoroscopy-guided Targeted Autologous Blood and Fibrin Glue Patching for Treatment
Cerebrospinal Fluid Leaks
Primary: Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline — -12; -7 score on a scale
N/A N=25 PMCF Study on CranioFix®2 System Used for the Fixation of Craniotomized Bone Flaps and Fractures
Skull Fractures
Primary: Planarity of Bone Flap After Implantation — 23; 0; 2; 17 Participants
N/A N=5 Structural Fat Grafting for Craniofacial Trauma: Repeat Fat Grafting Injection-5 Subject Cohort
Facial Injuries · Adipose Tissue
Primary: Facial Volume Score — 1.8; 2.2; 2.2; 2.6 units on a scale
N/A N=104 Open Complex Ventral Incisional Hernia Repair Using Biosynthetic Material for Midline Fascial Closure Reinforcement
Ventral Incisional Hernia
Primary: Hernia Recurrence Rate — 17.3 % of subjects with recurrent hernia
N/A N=15 Structural Fat Grafting for Craniofacial Trauma Using Manual Technique for Processing Fat Graft Material
Facial Injuries
Primary: Soft Tissue Volume After Autologous Fat Grafting Using CT Scans. — 11.4; 7.4; 6.5 milliliters
N/A N=6 An Analysis of Dermabond vs. Non-Absorbable Sutures in Skin Closure for Brow Ptosis Procedures
Brow Ptosis · Surgical Wound
Primary: Scar Appearance — 7; 2.33 score on a scale
N/A N=86 Bone Regenerative Techniques in Endodontic Microsurgery
Apical Periodontitis
Primary: 2D Radiographic Healing at 12 Months Follow up (Overall Cases) — 24; 29; 1; 1 osteotomy site
N/A N=14 Absorbable Suture Versus Tissue Glue to Repair Defects Following Mohs Surgery
Basal Cell Carcinoma · Squamous Cell Carcinoma
Primary: Visual Analog Scale (VAS) — 7.47; 7.97 units on a scale
N/A N=17 Musculotendinous Tissue Repair Unit and Reinforcement (MTURR)
Traumatic Injury · Muscle Injury · Tendon Injury
Primary: Percent Change From Baseline in the Rectified and Integrated EMG Signal of the Tibialis Anterior Muscle At 24 Weeks Post-Operative — 1333 % change
N/A N=41 Damage Control for Duodenal and Combined Duodenal-Pancreatic Injuries
Injury of Duodenum · Pancreatic Injury
Primary: Duodenal-related Complications — 13; 11; 8; 19 percentage of subjects
N/A N=20 A Study to Evaluate the Results of Facial Soft Tissue Reconstruction in Patients Who Have Suffered Traumatic Injury
Facial Injuries · Adipose Tissue
Primary: Volume — 0.576; 0.621 milliliters
N/A N=230 CorMatrix ECM for Carotid Repair Following Endarterectomy Registry
Carotid Stenosis
Primary: Carotid Procedure and Device Related Adverse Events to Determine Device Performance — 53; 10; 1; 2 Device related adverse events
N/A N=19 MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Nerve Injury
Primary: Michigan Hand Questionnaire (MHQ) in TPNI Subjects Post Surgery — 33; 83; 5; 75 score on a scale