CB-17-04/01 V2.0 Am1: SIC8000 in EMR for colonic lesions ≥20mm

  • Research type

    Research Study

  • Full title

    A randomized, double-blind, comparative, effectiveness and safety study of SIC 8000 in subjects undergoing Endoscopic Mucosal Resection (EMR) of colonic lesions equal to or larger than 2 cm.

  • IRAS ID

    222420

  • Contact name

    Richard Jones

  • Contact email

    rjones@cosmopharma.com

  • Sponsor organisation

    Cosmo Technologies Ltd.

  • Clinicaltrials.gov Identifier

    NCT02654418

  • Duration of Study in the UK

    0 years, 5 months, 31 days

  • Research summary

    This study is funded by Cosmo Technologies Ltd., a pharmaceutical/medical device company. This trial will test a new device to assist in the removal of large lesions in the colon which have a potential to become more serious lesions such as colorectal cancer. Removing such lesions when they are found is the standard clinical practice. The technique often used to remove large colon lesions is Endoscopic Mucosal Resection (EMR).
    For EMR, a liquid is injected under the lesion to “lift” it away from the surrounding tissue. This makes it easier to remove the lesion. SIC8000 is a liquid specifically made for this purpose. It contains very small amounts of a dye that helps visualise the edge of the lesion and to remove it completely.
    This is a Randomized Controlled Study (up to 3 months) - Randomization is a process where the group to which you are assigned is selected by chance. There are two treatment groups: Group 1 will receive an injection of ≤50 mL of SIC8000, Group 2 will receive standard of care injection for EMR. The randomization is 1:1 – like flipping a coin.
    Target recruitment is 250 subjects across 5 centres including USA, UK, Italy. Eligible subjects must be ≥18 with a colonic polyp ≥20 mm for removal by EMR.
    SIC8000 may make it easier for the removal of your large polyps and increase the ease of how your doctor will perform the EMR. It’s hoped the SIC8000 will increase the quality of the “lift” cushion created between your colon and polyps which will reduce the number of incisions required during EMR. It is also hoped the SIC8000 “lift” will last longer than the comparator standard-of-care used and will help your doctor complete the procedure more easily and with a lower volume of injectate.

  • REC name

    Wales REC 4

  • REC reference

    17/WA/0030

  • Date of REC Opinion

    23 Feb 2017

  • REC opinion

    Further Information Favourable Opinion