30 closest matches · ranked by relevance
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…
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…
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 /…
Chiari Malformation
Primary: Physical Health Quality of Life — 31.4; 35.61 units on a scale
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
Cranial Dura Repair
Primary: Absence of Cerebrospinal Fluid (CSF) Fistula and Pseudomeningocele — 57; 33 participants
Cerebrospinal Fluid Leak
Primary: Number of Participants With No CSF Leak During and After Surgery — 76; 87 Participants
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…
Spinal Procedure Requiring Dura Incision
Primary: Watertight Dural Closure — 102; 36 Participants
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
Postdural Puncture Headache · Post-Lumbar Puncture Headache · Cerebrospinal Fluid Leaks
Primary: Participants Who Report Post Dural Puncture Headaches — 21; 27 Participants — p=.877
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
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…
Aorta Thoracic; Traumatic Rupture
Primary: Number of Participants With Major Adverse Events — 0 number of serious adverse events
Pain Levels
Primary: Onset Time of Surgical Anesthesia — 422; 655 seconds
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
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…
Inguinal Hernia
Primary: Operative Time — 46; 43 minutes
Head Trauma · Craniocerebral Injuries · Crushing Skull Injury
Primary: Sensitivity of InfraScanner 2000 TM to Detect Any Size Hematoma at the Patient Level — 85.6 percentage
Rotator Cuff Tear
Primary: Western Ontario Rotator Cuff Index — 82; 80 score on a scale
Cerebrospinal Fluid Leaks
Primary: Change in Median (Headache Impact Test-6) HIT-6 Score From Baseline — -12; -7 score on a scale
Colorectal Cancer
Primary: Number of Participants With Major Colorectal Related Adverse Events: Leak, Stricture and Hemorrhage. — 4 Participants
Cataract
Primary: Participants With Complete Absence of Ocular Pain at Day 8 — 39; 39; 0; 1 Participants
Injury of Duodenum · Pancreatic Injury
Primary: Duodenal-related Complications — 13; 11; 8; 19 percentage of subjects
Low Back Pain
Primary: Hemoglobin Measurement g/dl — 66.2; 102.4 hemoglobin g/dl
Headache
Primary: Number of Patients (in Digits) Got Earlier Relief of PDPH (in Hours) After Use of Hydrocortisone or Mannitol. — 25; 25 Participants
Postdural Puncture Headache
Primary: Headache Pain Score — 6.67; 2.33 units on a scale
Post-Traumatic Headache
Primary: Frequency of Moderate or Severe Headache After Emergency Department (ED) Discharge — 31; 29; 42; 44 Participants — p=0.751
Osteoarthritis
Primary: WOMAC Functional Status - Difference From Baseline — 20.9; 18.5 Score — p=0.26
Hemiplegia
Primary: Rotator Cuff Tear of the Hemiplegic Shoulder, Confirmed by Ultrasonography — 29 participants