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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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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

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Adenomas

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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SIC 8000, 10 mL ampoules

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

Group Type EXPERIMENTAL

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

Intervention Type PROCEDURE

reference 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).

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Interventions

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. 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.
2. The base of the lesion should measure at least 20mm in at least one dimension.
3. 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.
4. ASA status: limited anesthesiology risk, with ASA score 1, 2 or 3.
5. 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.
6. 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.
7. Informed consent: signed written informed consent must be completed before inclusion in the study.

Exclusion Criteria

1. Age: Subjects under 18 years old are excluded
2. Consent: Subjects who refuse or who are unable to consent, vulnerable subjects are excluded.
3. Pregnancy: Pregnant or breastfeeding women
4. ASA status: High anesthetic risk (ASA score \> 3)
5. Physical findings: clinically significant abnormal physical findings which could interfere with the objectives of the study
6. Study participation: Subjects currently enrolled in any other clinical study or previous enrollment in a clinical study in the last 30 days
7. Subjects with Lesions less than 20 mm in largest dimension
8. Subjects with Lesions involving the muscularis propria (T2 lesions) on other staging modalities such as endoscopic ultrasonography (EUS)
9. Subjects with ulcerated depressed lesions (Paris type III) or biopsy proven invasive carcinoma
10. Presence of other malignant disease locally advanced or with metastasis
11. Presence of other lesions of the digestive tract as active Inflammatory colonic conditions (inflammatory bowel disease , e.g ulcerative colitis, Crohn's disease)
12. Endoscopic appearance of invasive malignancy
14. Previous partial resection or attempted resection of the target lesion is exclusionary.
15. 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.
16. known or suspected gastrointestinal obstruction or perforation, toxic megacolon, active diverticulitis.
17. inflammatory bowel disease e.g ulcerative colitis or Crohn's 's disease
18. Hemostasis disorders (eg Von Willebran disease, haemophilia or factor V Leiden thrombophilia), known clotting disorder (INR\>1.5 that cannot be corrected).
19. Other medical condition that in the investigator's opinion would make the administration of the study IMD or procedures hazardous to the subject.
20. Medical treatments (i.e.: radiotherapy, surgical endoscopic treatments) before the intervention.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes