SYNECOR Biomaterial NIS post-market clinical investigation

• Research type

  Research Study

• Full title

  Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application

• IRAS ID

  314047

• Contact name

  Chukwuma Abraham-Igwe

• Contact email

  Chukwuma.Abraham-Igwe@uhb.nhs.uk

• Sponsor organisation

  W.L. Gore and Associates Inc.

• Clinicaltrials.gov Identifier

  NCT05094089

• Duration of Study in the UK

  6 years, 7 months, 1 days

• Research summary

  Assessment of GORE® SYNECOR Biomaterial in Focused Patient Populations and Long-Term Application is a Non-interventional, prospective, multicenter, multicohort, international, post-market clinical investigation.

  The aim of the study is to obtain real-world observational evidence about the use of the device.

  The SYN 20-01 study population will consist of patients who present with ventral/incisional hernia disease requiring treatment per the evaluating physician.
  A total of 320 subjects will be implanted, divided among two cohorts:
  - SYNECOR IP Device: A total of 160 subjects implanted from Europe, 35
  subject site cap
  - SYNECOR PRE Device: A total of 160 subjects implanted from the United
  States, 35 subject site cap

  The study has been designed with standard eligibility criteria to enroll subjects for which the study device is intended to treat. Only patients who meet all of the inclusion criteria and none of the exclusion criteria will be implanted. All patients must provide informed consent prior to any study related procedures being
  performed and the patient is considered enrolled when informed consent is obtained.

  The primary objective of the SYN 20-01 study is to characterize the long-term performance of GORE® SYNECOR Biomaterial in patients requiring treatment for their ventral/incisional hernia. To facilitate this objective, differing methods of data collection (e.g., in-office, clinical examinations, remote data collection) will be utilized.

  All patients who sign an informed consent will be considered entered into the screening phase of the study and at the completion of study participation, subjects will be advised by their respective clinical centers on the appropriate follow-up regimen to be followed but it is expected that the First Post-Discharge visit will occur 14-90 days post procedure and the subsequent follow up visits windows will be annually for 5 years from the procedure date.

  Each enrolled and implanted subject will be followed up for 60 months (5 years).

• REC name

  West of Scotland REC 4

• REC reference

  22/WS/0090

• Date of REC Opinion

  19 Aug 2022

• REC opinion

  Further Information Favourable Opinion