Clinical trials: Extravasation Injury
Spinal Dural Defect, Cerebrospinal Fluid Leakage
Dural Medical Adhesive for Watertight Sealing in Dural Repair
This is a prospective, multicenter, single-blind, randomized controlled superiority clinical trial of dural medical adhesive for watertight sealing after primary spinal dural repair to prevent cerebrospinal fluid (CSF) leakage.
- Conditions
- Spinal Dural Defect, Cerebrospinal Fluid Leakage, Spinal Neurosurgery
- Trial name
- NCT07754344
- Testing
- Dural medical adhesive, Standard dural reinforcement surgery
- Where
- 6 sites in China
- Volunteers
- 141 people
- Sponsor
- Medprin Regenerative Medical Technologies Co., Ltd.
Cerebrospinal Fluid Leakage
Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy
This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.
- Trial name
- NCT01295619
- Testing
- I-020805
- Where
- 4 sites in Germany, Hungary
- Volunteers
- 41 people
- Sponsor
- Kuros Biosurgery AG
Cerebrospinal Fluid Leak
Evaluate the Safety and Efficacy of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a…
- Trial name
- ENCASE-II (NCT04086550)
- Testing
- LIQOSEAL, DuraSeal, Adherus
- Where
- 17 sites in United States, Austria and 5 more
- Volunteers
- 228 people
- Sponsor
- Polyganics BV
Infiltration, Extravasation
Monitoring the Peripheral Intravenous Infusion Site for Infiltration and Extravasation
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events.
- Conditions
- Infiltration, Extravasation, IV Infiltration, IV Extravasation
- Trial name
- NCT01476293
- Where
- United States
- Volunteers
- 139 people
- Sponsor
- ivWatch, LLC
Cerebrospinal Fluid Leakage
Study to Evaluate the Effectivity and Safety of BIOSCAFF®H Compared to DuraGen®, in Patients Undergoing Dural Repair
Study in which the presence or absence of symptoms or any health condition is observed and recorded 30 days after a cranial surgery in which the physician places a material or graft, either BIOSCAFF®H or DuraGen®, into the skull…
- Trial name
- NCT06419855
- Testing
- Human collagen matrix graft, Bovine collagen matrix graft
- Where
- 4 sites in Mexico
- Volunteers
- 2 people
- Sponsor
- Top Health S.A.P.I DE C.V.
Dura Mater Nick Cut or Tear, Hemostatis
Hemopatch Performance Evaluation: A Prospective Observational Registry
To assess the clinical performance and safety of HEMOPATCH Sealing Hemostat in a post-marketing setting in cardiovascular, thoracic, urologic, neurological, and other general surgical procedures.
- Conditions
- Dura Mater Nick Cut or Tear, Hemostatis, Air Leakage, Body Fluid Leakage
- Trial name
- NCT03392662
- Testing
- Hemopatch
- Where
- 15 sites in Austria, Czechia and 3 more
- Volunteers
- 621 people
- Sponsor
- Baxter Healthcare Corporation
Breast Cancer, Lumpectomy
Efficacy and Safety of Fibrin Sealant Vapor Heated Solvent/Detergent Treated (FS VH S/D) for Reduction of Lymphatic Leakage by Sealing Axillary Lymph Node Dissection Sites
This study will monitor the safety of FS VH S/D and will evaluate whether FS VH S/D is superior to conventional surgical procedures in the reduction of lymphatic leakage by sealing the axillary lymphatics in subjects undergoing…
- Conditions
- Breast Cancer, Lumpectomy, Mastectomy Plus Axillary Lymph Node Dissection, Lymphatic Leakage
- Trial name
- NCT00161980
- Testing
- Fibrin Sealant VH S/D, Surgical intervention alone without Fibrin Sealant VH S/D application
- Where
- 8 sites in Austria, France and 2 more
- Sponsor
- Baxter Healthcare Corporation
Intravenous Infiltration, Extravasation of Diagnostic and Therapeutic Materials
Optical Detection of Intravenous Infiltration
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration.
- Trial name
- NCT01126710
- Where
- United States
- Volunteers
- 263 people
- Sponsor
- CW Optics, Inc.
Cerebrospinal Fluid Leak
Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery
The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural…
- Trial name
- NCT03566602
- Testing
- Dura Sealant Patch
- Where
- 3 sites in Netherlands, Switzerland
- Volunteers
- 40 people
- Sponsor
- Polyganics BV
Leakage After Esophagectomy, Leakage After Gastrectomy
Eso-Sponge Registry
This international, prospective and multicenter registry was designed to collect clinical evidence for the endoscopic vacuum treatment using Eso-SPONGE® for anastomotic leakage after esophageal resection or iatrogenic or…
- Conditions
- Leakage After Esophagectomy, Leakage After Gastrectomy, Perforation of the Esophagus
- Trial name
- NCT02662777
- Testing
- Eso-SPONGE® vacuum treatment
- Where
- 17 sites in Germany
- Volunteers
- 108 people
- Sponsor
- Aesculap AG
Pancreatic Tumor, Benign, Pancreatic Neoplasms
Laser Tissue Welding - Distal Pancreatectomy Sealing Study
The laser tissue welding device is intended for use in patients requiring sealing of the pancreas after partial pancreatectomy, and including those patients who are fully heparinized or have hemodilutional coagulation failure.
- Conditions
- Pancreatic Tumor, Benign, Pancreatic Neoplasms, Pancreatic Adenocarcinoma, Pancreatic Pseudocyst
- Trial name
- LTW (NCT03147768)
- Testing
- Distal Pancreatectomy Sealing Using LTW
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Laser Tissue Welding, Inc.