Trials / Completed
CompletedNCT02654418
Safety Study of SIC 8000 in Subjects Undergoing Endoscopic Mucosal Resection (EMR) of Colonic Lesions Equal to or Larger Than 2 cm
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 226 (actual)
- Sponsor
- Cosmo Technologies Ltd · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) |
Timeline
- Start date
- 2016-02-01
- Primary completion
- 2017-05-01
- Completion
- 2017-07-01
- First posted
- 2016-01-13
- Last updated
- 2017-09-05
Locations
5 sites across 3 countries: United States, Italy, United Kingdom
Source: ClinicalTrials.gov record NCT02654418. Inclusion in this directory is not an endorsement.