Spots Global Cancer Trial Database for Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm

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Trial Identification

Brief Title: Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm

Official 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

Study ID: NCT02654418

Conditions

Adenomas

Interventions

Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)

Study Description

Brief Summary: SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare.

Detailed Description: SIC 8000 is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare. The current trial will focus on only colonic polyps ≥20 mm removed by snare EMR technique. Patients with lesions not suitable for EMR because of features strongly suggestive of sub-mucosal invasion will not be included.