NCT02654418

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
226

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 13, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 5, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

January 7, 2016

Last Update Submit

September 1, 2017

Conditions

Adenomas

Keywords

colonic polyps ≥20 mm,adenomaspolyps

Outcome Measures

Primary Outcomes (2)

  • Sydney Resection Quotient (size of polyp in mm divided by number of resection pieces).

    At V2 day of Endoscopic Mucosal resection of polyp (Day 1)

  • Proportion of subjects with en bloc resection of all endoscopically visible lesion

    At V2 day of endoscopy (Day 1)

Secondary Outcomes (12)

  • Effectiveness compared to the reference comparator in terms of injected volume to provide initial polyp lift

    At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  • Injected volume required to complete the procedure

    At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  • Number of re-injections required to complete the procedure

    At V2 day of Endoscopic Mucosal Resection (Day 1)

  • Number of resection pieces

    At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  • Ease of use rated on 5-point scale

    At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  • +7 more secondary outcomes

Study Arms (2)

SIC 8000, 10 mL ampoules

EXPERIMENTAL

Procedure/Surgery: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) with SIC 8000 injectate solution.

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

reference comparator

ACTIVE COMPARATOR

Procedure/Surgery: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) with Reference Comparator Injectate solution (site standard of care injectate solution).

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

Interventions

Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)PROCEDURE
SIC 8000, 10 mL ampoulesreference comparator

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Presence of treatment naïve, laterally spreading sessile, flat polyps or adenomas of the colon equal to or greater than 20 mm in largest dimension, assessed by the investigator to be suitable for EMR.
  • The base of the lesion should measure at least 20mm in at least one dimension.
  • A photograph demonstrating the lesion size ≥20 mm against a stiff Boston Scientific Captivator snare of 20 mm must be recorded for each patient prior to randomization.
  • ASA status: limited anesthesiology risk, with ASA score 1, 2 or 3.
  • Contraception: women of childbearing potential must use at least one reliable method of contraception or be abstinent. Women of non-child-bearing potential or in post-menopausal status must have been in that status for at least 1 year. For all women of child-bearing potential, serum pregnancy test result must be negative at screening.
  • Full comprehension: ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the investigator and to comply with the requirements of the entire study.

You may not qualify if:

  • Age: Subjects under 18 years old are excluded
  • Consent: Subjects who refuse or who are unable to consent, vulnerable subjects are excluded.
  • Pregnancy: Pregnant or breastfeeding women
  • ASA status: High anesthetic risk (ASA score \> 3)
  • Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
  • Study participation: Subjects currently enrolled in any other clinical study or previous enrollment in a clinical study in the last 30 days
  • Subjects with Lesions less than 20 mm in largest dimension
  • Subjects with Lesions involving the muscularis propria (T2 lesions) on other staging modalities such as endoscopic ultrasonography (EUS)
  • Subjects with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
  • Presence of other malignant disease locally advanced or with metastasis
  • Presence of other lesions of the digestive tract as active Inflammatory colonic conditions (inflammatory bowel disease , e.g ulcerative colitis, Crohn's disease)
  • Endoscopic appearance of invasive malignancy
  • Allergy: ascertained or presumptive hypersensitivity to study products; history of anaphylaxis to drugs or allergic reactions in general, which the investigator considers may affect the outcome of the study.
  • known or suspected gastrointestinal obstruction or perforation, toxic megacolon, active diverticulitis.
  • inflammatory bowel disease e.g ulcerative colitis or Crohn's 's disease
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Mayo Clinic

Jacksonville, Florida, FL 32224, United States

Location

Indiana University Hospital

Indianapolis, Indiana, IN 46290, United States

Location

Kansas City VA Hospital

Kansas City, Missouri, MO 64128, United States

Location

Humanitas Research Hospital & Humanitas University

Milan, Italy

Location

Queen Alexandra Hospital

Portsmouth, PO6 3LY, United Kingdom

Location

Related Publications (1)

  • Repici A, Wallace M, Sharma P, Bhandari P, Lollo G, Maselli R, Hassan C, Rex DK. A novel submucosal injection solution for endoscopic resection of large colorectal lesions: a randomized, double-blind trial. Gastrointest Endosc. 2018 Sep;88(3):527-535.e5. doi: 10.1016/j.gie.2018.04.2363. Epub 2018 May 8.

    PMID: 29750983DERIVED

MeSH Terms

Conditions

AdenomaPolyps

Condition Hierarchy (Ancestors)

Neoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Dr Douglas Rex

    Co-ordinating Investigator

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2016

First Posted

January 13, 2016

Study Start

February 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

September 5, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)US(3)IT(1)