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

NCT02654418 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2017-09-05

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Cosmo Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Dr Douglas Rex · Co-ordinating Investigator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-02-29
Primary Completion
2017-05-31
Completion
2017-07-31

Countries

  • United States
  • Italy
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02654418 on ClinicalTrials.gov