Ignite Creation Date:
2025-12-25 @ 5:04 AM
Ignite Modification Date:
2025-12-26 @ 4:07 AM
Study NCT ID:
NCT02654418
Status:
COMPLETED
Last Update Posted:
2017-09-05
First Post:
2016-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm
Sponsor:
Cosmo Technologies Ltd
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: