Clinical Trial: Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
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
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 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.
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.
Sponsor: Cosmo Technologies Ltd
Current Primary Outcome:
- 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) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- 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) [ 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 [ Time Frame: At V2 day of Endoscopic Mucosal Reseaction (Day 1) ]Histologist will assess if removed lesions have a free margin or not.
- 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 ]
Original Secondary Outcome: Same as current
Information By: Cosmo Technologies Ltd
Dates:
Date Received: January 7, 2016
Date Started: February 2016
Date Completion: May 2017
Last Updated: February 27, 2017
Last Verified: February 2017