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The focus of the study is to evaluate impact of submucosal injection of EverLift in achieving complete resection during polypectomy of polyps 4-9mm during colonoscopy.
The details of the proposed study are as follows:
Experimental group: using EverLift submucosal injection for polyps 4-9mm of the colon
Control group: not using EverLift submucosal injection for polyps 4-9mm of the colon
Methods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| With EverLift | Experimental | Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. |
|
| Without EverLift | Experimental | Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Use of EverLift | Device | Use of EverLift for submucosal injection prior to polypectomy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Polyps With Complete Resection | The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Resection | The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups. | During the procedure |
| Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shai Friedland, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Palo Alto Health Care System | Palo Alto | California | 94304 | United States |
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Each polyp sized 4-9 mm underwent block randomization to being removed by cold snare polypectomy (CNP) with or without submucosal injection of EverLift™.
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| ID | Title | Description |
|---|---|---|
| FG000 | Polypectomy With EverLift | Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. |
| FG001 | Polypectomy Without EverLift | Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Polypectomy With EverLift | Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. |
| BG001 | Polypectomy Without EverLift | Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Polyps With Complete Resection | The primary outcome measured is comparison of completeness of resection between the with EverLift and without EverLift groups. | Participants with polyps randomized the respective procedure are included in the analysis | Posted | Count of Units | Polyps | 2 weeks | Polyps | Polyps |
|
30 days
Patients who had the respective procedure were considered at risk for that procedure.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Polypectomy With EverLift | Polypectomy performed for polyps 4-9mm with submucosal injection of EverLift. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Splenic artery thrombosis | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shai Friedland, MD | Stanford University | 650-723-4000 | shaif@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 4, 2021 | Jun 21, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 4, 2022 | Jun 21, 2022 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| Without use of EverLift |
| Device |
Without use of EverLift for submucosal injection prior to polypectomy |
|
| During the procedure (up to 10 minutes) |
| Number of Patients With Procedural Complications | Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality. | 4 weeks (from procedure through 30 day follow-up) |
| BG002 | Total | Total of all reporting groups |
| Polyps |
|
| Participants |
| Participants |
|
| Sex/Gender, Customized | Number | participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants | Participants |
|
| Region of Enrollment | Number | participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Polyps |
|
|
|
| Secondary | Time to Resection | The time between the snare is introduced till the polyp is removed and retrieved will be compared between the with and without EverLift groups. | Participants with polyps randomized the respective procedure are included in the analysis | Posted | Mean | Standard Deviation | Seconds | During the procedure | Polyps | Polyps |
|
|
|
|
| Secondary | Number of Polyps Requiring Multiple Snare Attempts to Achieve Complete Endoscopic Polypectomy. | Participants with polyps randomized the respective procedure are included in the analysis | Posted | Count of Units | Polyps | During the procedure (up to 10 minutes) | Polyps | Polyps |
|
|
|
|
| Secondary | Number of Patients With Procedural Complications | Procedural complications include perforation and immediate post-polypectomy bleeding, early post-polypectomy bleed (within 24 hours) and delayed post polypectomy bleed (between 24 hours and 30 days). Early post-polypectomy bleed and delayed post-polypectomy bleed is evaluated based on emergency room (ER) visit, inpatient stay, transfusion needed, repeat colonoscopy required, surgical intervention required, and mortality. | Participants with polyps randomized the respective procedure are included in the analysis | Posted | Count of Participants | Participants | 4 weeks (from procedure through 30 day follow-up) |
|
|
|
| 0 |
| 105 |
| 1 |
| 105 |
| 0 |
| 105 |
| EG001 | Polypectomy Without EverLift | Polypectomy performed for polyps 4-9mm without submucosal injection of EverLift. | 0 | 109 | 2 | 109 | 0 | 109 |
| Post-polypectomy bleeding | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |