The EVICEL® GI Study

• Research type

  Research Study

• Full title

  A Single Blind, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® as an Adjunct to Gastrointestinal Anastomosis Techniques

• IRAS ID

  100908

• Contact name

  Charles Maxwell-Armstrong

• Sponsor organisation

  Omrix Biopharmacueticals

• Eudract number

  2011-005479-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  This is a single blind, randomized, multi-center controlled study evaluating the safety and effectiveness of EVICEL© in reducing the incidence of anastomotic leak following low anterior resesection when used as an adjunct to stapled gastrointestinal (GI) anastomosis. The study treatment is compared to standard of care (anastomosis without the use of adjunctive treatment).

• REC name

  East Midlands - Derby Research Ethics Committee

• REC reference

  12/EM/0089

• Date of REC Opinion

  23 Mar 2012

• REC opinion

  Further Information Favourable Opinion