Status:
COMPLETED
The Paediatric EVICEL® Soft Tissue and Parenchymal Organ Bleeding Study
Lead Sponsor:
Ethicon, Inc.
Conditions:
Hemorrhage
Soft Tissue Bleeding
Eligibility:
All Genders
Up to 17 years
Phase:
PHASE3
Brief Summary
To evaluate the safety and effectiveness of EVICEL® Fibrin Sealant (Human) as an adjunct to achieve haemostasis during surgery in paediatric patients.
Detailed Description
This is a prospective, randomized, controlled, clinical study comparing EVICEL® to SURGICEL®, as an adjunct to haemostasis when conventional methods of controlling bleeding are ineffective or impracti...
Eligibility Criteria
Inclusion
- Paediatric subjects birth to \<18 years of age, requiring non-emergent laparoscopic or open (through peritoneum or pleura) abdominal, retroperitoneal, pelvic or thoracic (non-cardiac) surgical procedures. i) The first 36 subjects to be enrolled will be subjects ≥1 years to \<18 years of age. ii) The next 4 subjects to be enrolled will be subjects birth to \<1years of age.
- The subject 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; and
- Presence of an appropriate mild or moderate bleeding soft tissue or parenchymal organ Target Bleeding Site identified intra-operatively by the surgeon;
Exclusion
- Subjects with known intolerance to blood products or to one of the components of the study product or is unwilling to receive blood products;
- Female subjects, who are of childbearing age (i.e. adolescent), who are pregnant or nursing;
- 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;
- Subjects who are known, current alcohol and/or drug abusers;
- Subjects admitted for trauma surgery;
- Subjects with any pre or intra-operative findings identified by the surgeon that may preclude conduct of the study procedure;
- Subjects with Target Bleeding Site in an actively infected field (Class III Contaminated or Class IV Dirty or Infected)
- Anastomotic bleeding sites will not be considered for randomization.
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 17 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02227706
Start Date
August 1 2014
End Date
May 17 2019
Last Update
August 31 2020
Active Locations (13)
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1
Clinical Investigation Site #31
Brussels, Belgium
2
Clinical Investigation Site #42
Hamilton, Ontario, Canada
3
Clinical Investigation Site #40
Toronto, Ontario, Canada
4
Clinical Investigation Site #41
Montreal, Quebec, Canada