A Study of the Safety of Using SIC 8000 in Patients Undergoing Endoscopic Mucosal Removal of Colon Lesions Equal to or Larger Than 2 cm

Overview

  • Study type

    Interventional
  • Study phase

    I
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Jacksonville, Florida: 16-000877
    NCT ID: NCT02654418
    Sponsor Protocol Number: CB-17-04/01

About this study

The purpose of this study is to assess the effectiveness of SIC 8000 injected into the submucosa under polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions to provide a lift to them prior to grasping and cutting with a snare during endoscopic removal procedures.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • 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
  • Limited anesthesiology risk, with ASA score 1, 2 or 3
  • 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
  • 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
  • Signed written informed consent must be completed before inclusion in the study

Exclusion Criteria:

  • Subjects under 18 years old
  • Subjects who refuse or who are unable to consent
  • Vulnerable subjects
  • Pregnant or breastfeeding women
  • High anesthetic risk ASA score > 3
  • Clinically significant abnormal physical findings which could interfere with the objectives of the study
  • 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
  • Previous treatment of the lesion (radiotherapy, endoscopy, surgery, chemotherapy)
    • Previous cold biopsy of the target lesion is not an exclusion criteria
  • Previous partial resection or attempted resection of the target lesion
  • 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
  • Hemostasis disorders (eg Von Willebran disease, haemophilia or factor V Leiden thrombophilia), known clotting disorder (INR>1.5 that cannot be corrected)
  • Other medical condition that in the investigator's opinion would make the administration of the study IMD or procedures hazardous to the subject
  • Medical treatments (i.e.: radiotherapy, surgical endoscopic treatments) before the intervention

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Michael Wallace, M.D.

Closed for enrollment

Additional contact information

Non-cancer trials contact form

Phone: 800-664-4542 (toll-free)

International patient clinical studies questions