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Adenoma detection rate (ADR) is a validated marker for reducing the risk of interval colorectal cancer after a screening colonoscopy. Recent studies suggest that novel devices attached to the colonoscope tip may improve the ADR of doctors performing a screening procedure
Recent studies indicate that continuing medical education, time of colonoscopy during the day, forced longer withdrawal time, use of high definition colonoscopes all result in improving ADR although the gains have only been modest. To this end, adding novel devices to the tip of colonoscope may improve the ability of doctors to perform a better procedure. We therefore propose to identify the increase in ADR with 3 of these devices compared to standard colonoscopy. Fuse colonoscopy (2 cameras embedded at the side of the colonoscope tip providing an increased angle of view), EndoCuff (a plastic cap to fit the tip with flexible arms which hold the mucosa back aiding in inspection), EndoRings (similar to EndoCuff but the arms are wider) have been shown in tandem colonoscopy studies to improve the adenoma miss rates to 7-15% instead of the miss rates seen with standard colonoscopy which is usually about 40%. All these devices are FDA approved and are distributed in the United States.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FUSE® Colonoscopy | Active Comparator | A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy |
|
| Colonoscopy with EndoCuff™ | Active Comparator | An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope |
|
| Colonoscopy with EndoRings™ | Active Comparator | An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope |
|
| Standard Colonoscopy | Active Comparator | A standard colonoscope will be used to complete the procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscopy with EndoCuff™ | Device | colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenomas Per Colonoscopy | During Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Detected Adenoma | During Procedure | |
| Percentage of Participants With Detected Adenoma | During Procedure | |
| Sessile Serrated Polyps Per Colonoscopy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Rex, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University Hospital | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29530353 | Derived | Rex DK, Repici A, Gross SA, Hassan C, Ponugoti PL, Garcia JR, Broadley HM, Thygesen JC, Sullivan AW, Tippins WW, Main SA, Eckert GJ, Vemulapalli KC. High-definition colonoscopy versus Endocuff versus EndoRings versus full-spectrum endoscopy for adenoma detection at colonoscopy: a multicenter randomized trial. Gastrointest Endosc. 2018 Aug;88(2):335-344.e2. doi: 10.1016/j.gie.2018.02.043. Epub 2018 Mar 9. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard Colonoscopy | A standard colonoscope will be used to complete the procedure Standard Colonoscopy: Current standard of care colonoscopy |
| FG001 | Colonoscopy With EndoCuff™ | An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope |
| FG002 | Colonoscopy With EndoRings™ | An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
| FG003 | FUSE® Colonoscopy | A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard Colonoscopy | A standard colonoscope will be used to complete the procedure Standard Colonoscopy: Current standard of care colonoscopy |
| BG001 | Colonoscopy With EndoCuff™ |
| 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 | Adenomas Per Colonoscopy | The number of adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Mean | Standard Deviation | Adenomas per Colonoscopy | During Procedure |
|
28 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 | Standard Colonoscopy | A standard colonoscope will be used to complete the procedure Standard Colonoscopy: Current standard of care colonoscopy |
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| 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 | Apr 9, 2015 | Feb 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| FUSE® Colonoscopy | Device | colonoscopy performed with the FUSE® (full spectrum endoscopy) system |
|
| Colonoscopy with EndoRings™ | Device | colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
|
| Standard Colonoscopy | Device | Current standard of care colonoscopy |
|
| During Procedure |
| Number of Participants With Detected Sessile Serrated Polyp | Number of patients with 1 or more sessile serrated polyps | During Procedure |
| Percentage of Participants With Detected Sessile Serrated Polyp | During Procedure |
| Number of Participants With a Detected Polyp | During Procedure |
| Percentage of Participants With a Detected Polyp | During Procedure |
| Cecal Insertion Time | During Procedure |
| Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | During Procedure |
| Inspection Time | During Procedure |
| Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure |
| Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure |
| Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure |
| Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | During Procedure |
| Polyposis identified during procedure |
|
| Recognized ineligible post-randomization |
|
| Ulcerative Colitis identified |
|
| Cecum not intubated |
|
An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope
Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
| BG002 | Colonoscopy With EndoRings™ | An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
| BG003 | FUSE® Colonoscopy | A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Indication | Count of Participants | Participants | No |
|
| OG002 | Colonoscopy With EndoRings™ | An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope |
| OG003 | FUSE® Colonoscopy | A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system |
|
|
| Secondary | Number of Participants With Detected Adenoma | The number of participants with detected adenomas was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Count of Participants | Participants | No | During Procedure |
|
|
|
| Secondary | Percentage of Participants With Detected Adenoma | The number of participants analyzed differed because the calculation was done for all three sites overall and then broken down into each specific site. Thus, only patients randomized to the treatment arm at that site were included in the specific site calculations instead of including the total number of patients randomized to that treatment arm. | Posted | Number | Percentage of Participants | During Procedure |
|
|
|
| Secondary | Sessile Serrated Polyps Per Colonoscopy | The number of sessile serrated polyps per colonoscopy was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Mean | Standard Deviation | Sessile Serrated Polyps per colonoscopy | During Procedure |
|
|
|
| Secondary | Number of Participants With Detected Sessile Serrated Polyp | Number of patients with 1 or more sessile serrated polyps | The number of participants with detected sessile serrated polyps was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Count of Participants | Participants | No | During Procedure |
|
|
|
| Secondary | Percentage of Participants With Detected Sessile Serrated Polyp | The number of participants analyzed for each site differed because the percentage of patients with a sessile serrated polyp was calculated specifically for the site. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm. | Posted | Number | Percentage of Participants | During Procedure |
|
|
|
| Secondary | Number of Participants With a Detected Polyp | The number of participants with a detected polyp was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Count of Participants | Participants | No | During Procedure |
|
|
|
| Secondary | Percentage of Participants With a Detected Polyp | The number of participants analyzed for each site differed because the percentage of patients with a polyp was calculated for each site specifically. Thus, only patients randomized to the treatment arm at that site were included in the calculation instead of including the total number of patients randomized to the treatment arm. | Posted | Number | Percentage of Participants | During Procedure |
|
|
|
| Secondary | Cecal Insertion Time | The mean insertion time was calculated overall for all three sites and then broken down into individual sites. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Mean | Standard Deviation | Seconds | During Procedure |
|
|
|
| Secondary | Cecal Insertion Times When no Gastroenterology Fellow Was Involved in Insertion | Gastroenterology fellows were allowed to assist in inserting the scope, but times included in this analysis were from insertions done completely by the physician. This is why the overall number analyzed differs from the number analyzed in other outcome measure as well as why the numbers differ depending on site and randomization arm. | Posted | Mean | Standard Deviation | Seconds | During Procedure |
|
|
|
| Secondary | Inspection Time | The mean inspection time of all three sites overall was calculated as well as the mean inspection time for each individual site. The number of participants in each arm differed at each site, which is why the number analyzed differs depending on site and randomization. | Posted | Mean | Standard Deviation | Seconds | During Procedure |
|
|
|
| Secondary | Number of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | Posted | Number | Adenomas | During Procedure |
|
|
|
| Secondary | Percent of Conventional Adenomas by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | Posted | Number | Percentage of Adenomas | During Procedure |
|
|
|
| Secondary | Number of Sessile Serrated Polyps by Size in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | Posted | Number | Sessile Serrated Polyps | During Procedure |
|
|
|
| Secondary | Percent of Sessile Serrated Polyps in the Right Side of the Colon, Which Includes the Cecum, Ascending Colon, and Hepatic Flexure. | Posted | Number | Percentage of Sessile Serrated Polyps | During Procedure |
|
|
|
| 0 |
| 295 |
| 0 |
| 295 |
| 0 |
| 295 |
| EG001 | Colonoscopy With EndoCuff™ | An EndoCuff™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoCuff™: colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope | 0 | 299 | 0 | 299 | 0 | 299 |
| EG002 | Colonoscopy With EndoRings™ | An EndoRings™ distal attachment will be placed at the distal end of a standard colonoscope Colonoscopy with EndoRings™: colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope | 0 | 295 | 0 | 295 | 0 | 295 |
| EG003 | FUSE® Colonoscopy | A FUSE® system with 3 HD (high-definition) monitors will be used to perform the colonoscopy FUSE® Colonoscopy: colonoscopy performed with the FUSE® (full spectrum endoscopy) system | 0 | 299 | 0 | 299 | 0 | 299 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Title | Measurements |
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| 1-5mm |
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| 6-9mm |
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| greater than or equal to 10mm |
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| 6-9mm |
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| greater than or equal to 10mm |
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| 1-5mm |
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| 6-9mm |
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| greater than or equal to 10mm |
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| 6-9mm |
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| greater than or equal to 10mm |
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