EUCTR2013-003401-26-GB
Active, not recruiting
Phase 1
A Prospective, Randomized, Controlled, Study Evaluating EVICEL® Fibrin Sealant as an Adjunct to Hemostasis During Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery in Pediatric Patients - The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
ConditionsAbdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) SurgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]
DrugsEVICEL®
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Abdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) Surgery
- Sponsor
- Ethicon Inc.
- Enrollment
- 40
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pre\-operative:
- •1\. Paediatric subjects birth to \< 18 years of age, requiring non\-emergent laparoscopic or open abdominal, retroperitoneal, pelvic, or thoracic (non\-cardiac) surgical procedures;
- •2\. The subject’s and/or subject’s parent or legal guardian must be willing to give permission for the subject to participate in the trial, and provide written informed consent for the subject. If possible, assent must be obtained from paediatric subjects who possess the intellectual and emotional ability to comprehend the concepts involved in the trial. If the paediatric subject is not able to provide assent (due to age, maturity and/or inability to intellectually and/or emotionally comprehend the trial), the parent/legal guardian’s written informed consent for the subject will be acceptable for the subject to be included in the study.
- •Intra\-operative:
- •3\. Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra\-operatively by the surgeon;
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 40
- •F.1\.2 Adults (18\-64 years) no
- •F.1\.2\.1 Number of subjects for this age range
- •F.1\.3 Elderly (\>\=65 years) no
Exclusion Criteria
- •Pre\-operative:
- •1\. Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- •2\. Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
- •3\. Subject is currently participating or, during the study is planned to participate in any other investigational device or drug trial without prior approval from the Sponsor;
- •4\. Subjects who are known, current alcohol and/or drug abusers
- •5\. Subjects admitted for trauma surgery
- •6\. Subjects with any pre or intra\-operative findings identified by the surgeon that may preclude conduct of the study procedure.
- •Intra\-operative:
- •7\. Subject with TBS in an actively infected field (Class III Contaminated or Class IV Dirty or Infected);
- •8\. Anastomotic bleeding sites will not be considered for randomization
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study of the safety and effectiveness of EVICEL® as a treatment in addition to standard techniques of stopping bleeding during abdominal surgery in childreAbdominal, Retroperitoneal, Pelvic or Thoracic (Non-Cardiac) SurgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]EUCTR2013-003401-26-BEEthicon Inc.40
Active, not recruiting
Phase 1
Study Evaluating the safety and effectiveness of EVICEL® used for Suture-line sealing to provide a watertight closure during Paediatric Neurosurgical ProceduresEUCTR2013-003558-26-GBEthicon Inc42
Active, not recruiting
Phase 1
A study evaluating the effect of EVARREST® Fibrin Sealant Patch as as an adjunct to haemostasis in controlling mild to moderate bleeding during open surgery in paediatric patientsEUCTR2013-003557-24-GBEthicon Inc40
Active, not recruiting
Phase 1
A study evaluating the effect of EVARREST® Fibrin Sealant Patch as as an adjunct to haemostasis in controlling mild to moderate bleeding during open surgery in paediatric patientsMild or moderate hepatic parenchyma or soft tissue bleeding duringopen, abdominal, retroperitoneal, pelvic and thoracic (non-cardiac) surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]EUCTR2013-003557-24-BEEthicon Inc40
Completed
Not Applicable
A Clinical study to evaluate the glycemic index of 11 rice samples in healthy volunteersCTRI/2011/10/002035Marico Ltd30