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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size) | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Douglas Rex | Co-ordinating Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | FL 32224 | United States | ||
| Indiana University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29750983 | Derived | 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. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 5, 2020 | |
| Reset | Feb 20, 2020 |
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| 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) |
| Time to resect the lesion completely | At V2 day of Endoscopic Mucosal Reseaction (Day 1) |
| Number of single session complete removal of lesions | At V2 day of Endoscopic Mucosal Reseaction (day 1) |
| Need for additional treatment modalities (eg coagulation, ablation, avulsion) | At V2 day of Endoscopic Mucosal Reseaction (Day 1) |
| Pathology negative report for lateral and/or deep margins | At V2 day of Endoscopic Mucosal Reseaction (Day 1) |
| Number of deep resections containing muscularis propria | At V2 day of Endoscopic Mucosal Reseaction (Day 1) |
| Histologically positive or negative Free margin confirmed in en-bloc resections | Histologist will assess if removed lesions have a free margin or not. | At V2 day of Endoscopic Mucosal Reseaction (Day 1) |
| Recurrent or residual neoplasia confirmed by repeat standard endoscopy and biopsy (if applicable) at the follow up visit | Day 60 follow up visit |
| Indianapolis |
| Indiana |
| IN 46290 |
| United States |
| Kansas City VA Hospital | Kansas City | Missouri | MO 64128 | United States |
| Humanitas Research Hospital & Humanitas University | Milan | Italy |
| Queen Alexandra Hospital | Portsmouth | PO6 3LY | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 5, 2020 | Feb 20, 2020 |
| ID | Term |
|---|---|
| D000236 | Adenoma |
| D011127 | Polyps |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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