The EVARREST® Pediatric Single Arm Mild/Moderate Liver & Soft Tissue
Research type
Research Study
Full title
A Prospective Study Evaluating the Safety and Effectiveness of EVARREST® Fibrin Sealant Patch in Controlling Mild or Moderate Hepatic Parenchyma or Soft Tissue Bleeding During Open Abdominal, Retroperitoneal, Pelvic and Thoracic (non-cardiac) Surgery in Pediatric Patients
IRAS ID
286724
Contact name
Emily Valerio
Contact email
Sponsor organisation
Ethicon Inc
Eudract number
2019-004657-89
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 29 days
Research summary
This is an open-label, multicenter, single-arm study evaluating the safety and effectiveness of EVARREST in controlling mild or moderate bleeding in hepatic parenchyma or soft tissue during Open Abdominal, Retroperitoneal, Pelvic
and Thoracic (non-cardiac) Surgery for which standard methods of achieving Hemostasis are ineffective or impractical. For this study, approximately 12 sites in US and UK will be utilized for consecutive screening and enrollment. Eligible subjects will be treated with EVARREST. Absolute time to haemostasis will be assessed as well as haemostasis at 4 and 10 minutes from randomisation. Subjects will be followed post-operatively through discharge and at 30 days (+/-14 days) post-surgery.
At least thirty-five (35) qualified paediatric subjects with an appropriate mild or moderate bleeding TBS will be enrolled in this study. Enrolment will be staggered by age (as required by EMA Paediatric Committee). The first31 subjects enrolled will be aged ≥1 year to <18 years of age and the subsequent 4 subjects will include 4 subjects from 1 month (≥ 28 days from birth) to <1 years of age. Ongoing safety assessment will ensure adequate safety monitoring occur during the staged enrollment.REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
20/EM/0257
Date of REC Opinion
14 Dec 2020
REC opinion
Further Information Favourable Opinion