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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
226
Mayo Clinic
Jacksonville, Florida, United States
Indiana University Hospital
Indianapolis, Indiana, United States
Kansas City VA Hospital
Kansas City, Missouri, United States
Humanitas Research Hospital & Humanitas University
Milan, Italy
Sydney Resection Quotient (size of polyp in mm divided by number of resection pieces).
Time frame: At V2 day of Endoscopic Mucosal resection of polyp (Day 1)
Proportion of subjects with en bloc resection of all endoscopically visible lesion
Time frame: At V2 day of endoscopy (Day 1)
Effectiveness compared to the reference comparator in terms of injected volume to provide initial polyp lift
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Injected volume required to complete the procedure
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Number of re-injections required to complete the procedure
Time frame: At V2 day of Endoscopic Mucosal Resection (Day 1)
Number of resection pieces
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Ease of use rated on 5-point scale
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Time to resect the lesion completely
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Number of single session complete removal of lesions
Time frame: At V2 day of Endoscopic Mucosal Reseaction (day 1)
Need for additional treatment modalities (eg coagulation, ablation, avulsion)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Queen Alexandra Hospital
Portsmouth, United Kingdom
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Pathology negative report for lateral and/or deep margins
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Number of deep resections containing muscularis propria
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Histologically positive or negative Free margin confirmed in en-bloc resections
Histologist will assess if removed lesions have a free margin or not.
Time frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1)
Recurrent or residual neoplasia confirmed by repeat standard endoscopy and biopsy (if applicable) at the follow up visit
Time frame: Day 60 follow up visit