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This study seeks to compare colonoscopy results between a standard method and one using a distal scope attachment (Endocuff Vision).
For this study, subjects will be randomized into one of two groups (those who receive a standard colonoscopy and those who receive a colonoscopy with an Endocuff Vision attachment). Results will then be compared between the two; these include insertion time (time it takes to reach the cecum of the large intestine), inspection time (time spent examining the large intestine), the total time per each polypectomy (removal of polyps in the colon), and the total procedure time of the colonoscopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm (Standard Colonscopy) | No Intervention | Standard colonoscopy with no device attachments | |
| Endocuff Vision | Experimental | Colonoscopy with Endocuff Vision attached to distal end of scope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocuff Vision | Device | Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch. | During the withdrawal portion of the colonoscopy procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached. | During the insertion portion of the colonoscopy procedure |
| Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas K Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28412271 | Background | Tsiamoulos ZP, Misra R, Rameshshanker R, Elliott TR, Beintaris I, Thomas-Gibson S, Haycock A, Suzuki N, Rees C, Saunders BP. Impact of a new distal attachment on colonoscopy performance in an academic screening center. Gastrointest Endosc. 2018 Jan;87(1):280-287. doi: 10.1016/j.gie.2017.04.001. Epub 2017 Apr 13. | |
| 30659990 | Derived |
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De-identified data can be shared in the future upon request.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Arm (Standard Colonscopy) | Standard colonoscopy with no device attachments |
| FG001 | Endocuff Vision | Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Endocuff Vision | Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Inspection Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Inspection time is time spent actually examining the colon. This was measured with a stopwatch and calculated by subtracting washing, suctioning, polypectomy and biopsy times from total withdrawal time. It was measured during colonoscopy by a study assistant using a stopwatch. | Posted | Mean | Standard Error | Minutes | During the withdrawal portion of the colonoscopy procedure |
|
5 months
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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 | Control Arm (Standard Colonscopy) | Standard colonoscopy with no device attachments |
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Examiners were not blinded to the device used. Only 2 examiners with experience with the device participated in the study so generalizability of the results is unknown.
Data was not collected on other potential confounders like smoking or BMI.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rachel Lahr | Indiana University | 3179480724 | rlahr@iu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 10, 2018 | Apr 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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Total procedure time is the time from the initial insertion through the complete withdrawal of the scope |
| During the colonoscopy procedure |
| Detection Rates | The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision. | During the colonoscopy procedure |
| Polyps Per Colonoscopy | Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision. | During the colonoscopy procedure |
| Boston Bowel Preparation Score | Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist. | During the withdrawal portion of the colonoscopy procedure after cleaning of the colon |
| Rex DK, Slaven JE, Garcia J, Lahr R, Searight M, Gross SA. Endocuff Vision Reduces Inspection Time Without Decreasing Lesion Detection: A Clinical Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jan;18(1):158-162.e1. doi: 10.1016/j.cgh.2019.01.015. Epub 2019 Jan 17. |
| Control Arm (Standard Colonscopy) |
Standard colonoscopy with no device attachments |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Gastroenterology fellows assisting in insertion | Count of Participants | Participants |
|
| Procedure Indication | Count of Participants | Participants |
|
Standard colonoscopy with no device attachments |
|
|
| Secondary | Insertion Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Insertion time is the time it takes from the colonoscope first being inserted to when the furthest section of the colon (which is called the cecum) is reached. | Posted | Mean | Standard Error | Minutes | During the insertion portion of the colonoscopy procedure |
|
|
|
| Secondary | Total Procedure Time Comparisons for Each Method (Standard vs. Endocuff Vision) | Total procedure time is the time from the initial insertion through the complete withdrawal of the scope | Posted | Mean | Standard Deviation | Minutes | During the colonoscopy procedure |
|
|
|
| Secondary | Detection Rates | The percentage of participants with at least one of the indicated polyp types found during standard colonoscopy compared to colonoscopy with Endocuff Vision. | Posted | Mean | 95% Confidence Interval | Percentage of Participants | During the colonoscopy procedure |
|
|
|
| Secondary | Polyps Per Colonoscopy | Number of adenomas or sessile serrated polyps found per colonoscopy of Standard colonoscopy compared to Colonoscopy with Endocuff Vision. | Posted | Mean | Standard Error | Polyps per colonoscopy | During the colonoscopy procedure |
|
|
|
| Secondary | Boston Bowel Preparation Score | Boston Bowel Preparation Score for patients receiving standard colonoscopy compared to colonoscopy with endocuff vision. The total score for the Boston Bowel Preparation Scale ranges from 0 to 9, with higher score indicating a better bowel preparation quality. The quality of the bowel preparation is assessed by the attending gastroenterologist. | Posted | Median | Full Range | Scores on a scale | During the withdrawal portion of the colonoscopy procedure after cleaning of the colon |
|
|
|
| 0 |
| 99 |
| 0 |
| 99 |
| 0 |
| 99 |
| EG001 | Endocuff Vision | Colonoscopy with Endocuff Vision attached to distal end of scope Endocuff Vision: Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure. | 0 | 101 | 0 | 101 | 0 | 101 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |