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AdenomasNCT02654418

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

A study testing Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) in people with Adenomas, run by Cosmo Technologies Ltd at 5 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Adenomas
What is being tested?
Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
226 participants
Where
5 sitesin 3 countries
Study dates
Feb 2016to Jul 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
  • Informed consent: signed written informed consent must be completed before inclusion in the study.

Who cannot join

  • 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
Show all 20Show fewer
  • 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) is exclusionary. Previous cold biopsy of the target lesion is not an exclusion criteria.
  • Previous partial resection or attempted resection of the target lesion is exclusionary.
  • 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
  • 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.

Trial locations and contacts

5 sites in 3 countries.

5 sites in 3 countries

United States3 sites

  • Indiana University Hospital

    Indianapolis, Indiana, IN 46290

  • Mayo Clinic

    Jacksonville, Florida, FL 32224

  • Kansas City VA Hospital

    Kansas City, Missouri, MO 64128

Other trials in United States

Italy1 site

  • Humanitas Research Hospital & Humanitas University

    Milan

Other trials in Italy

United Kingdom1 site

  • Queen Alexandra Hospital

    Portsmouth, PO6 3LY

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the 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
Adenomas
Being tested
Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)
Keywords
colonic polyps ≥20 mm,, adenomas, polyps
Medical subject headings
Adenoma, Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT02654418
Study groupRoleWhat they receive
SIC 8000, 10 mL ampoulesExperimentalProcedure/Surgery: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) with SIC 8000 injectate solution.
Receives: Procedure: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)
reference comparatorActive comparatorProcedure/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).
Receives: Procedure: Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

  2. Proportion of subjects with en bloc resection of all endoscopically visible lesion

    Measured: At V2 day of endoscopy (Day 1)

Secondary outcomes (12)

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

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  2. Injected volume required to complete the procedure

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  3. Number of re-injections required to complete the procedure

    Measured: At V2 day of Endoscopic Mucosal Resection (Day 1)

  4. Number of resection pieces

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  5. Ease of use rated on 5-point scale

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  6. Time to resect the lesion completely

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  7. Number of single session complete removal of lesions

    Measured: At V2 day of Endoscopic Mucosal Reseaction (day 1)

  8. Need for additional treatment modalities (eg coagulation, ablation, avulsion)

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  9. Pathology negative report for lateral and/or deep margins

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  10. Number of deep resections containing muscularis propria

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  11. Histologically positive or negative Free margin confirmed in en-bloc resections

    Histologist will assess if removed lesions have a free margin or not.

    Measured: At V2 day of Endoscopic Mucosal Reseaction (Day 1)

  12. Recurrent or residual neoplasia confirmed by repeat standard endoscopy and biopsy (if applicable) at the follow up visit

    Measured: Day 60 follow up visit

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2016 (estimated)
  2. Study startFeb 2016
  3. Primary completionMay 2017
  4. Study completionJul 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
226 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02654418
Sponsor's protocol ID
CB-17-04/01
Status last verified
Feb 2017
First submitted
7 Jan 2016
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 29750983

Questions about this trial

What is this clinical trial studying?

A study testing Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) in people with Adenomas, run by Cosmo Technologies Ltd at 5 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States, Italy, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sydney Resection Quotient (size of polyp in mm divided by number of resection pieces). (time frame: At V2 day of Endoscopic Mucosal resection of polyp (Day 1)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02654418, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

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