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Covid-19 restrictions with screening/surveillance colonoscopies
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Colorectal cancer is the second-leading cause of cancer death in the United States. Colorectal cancer screening is recommended to begin at age 50 years for most men and women at average risk for this disease. Colonoscopy is a gold standard method of screening for colorectal cancer, allowing for the detection and removal of colorectal polyps, some of which can progress into malignancy. The literature has shown that the removal of polyps during a colonoscopy results in decreased incidence and mortality related to colorectal cancer. Indeed, the last decade has shown a decline in colorectal cancer incidence and mortality in adults over age 50, largely due to increased colonoscopy screening. Currently, the risk of a patient developing colorectal cancer and thus time intervals for colonoscopy surveillance post-polypectomy is determined by the number, pathology, and size of the polyps that are observed and removed during the colonoscopy procedure. Current surveillance guidelines indicate the need for a shorter interval before the next colonoscopy for patients who have one or more polyps that are 10mm or larger. In addition, different polypectomy techniques are indicated for the treatment of polyps less than 20mm in size. For example, cold forceps may be appropriate for removal of 1mm to 2mm polyps, cold snare for polyps less than 10mm, and hot-snare resection for polyps 10mm to 19mm. Yet, while the number and pathology of polyps are easily obtained and verified, it is standard practice for the size of a polyp to be assessed through endoscopist optical visualization alone, without use of an objective device or standard by which to measure it. Often, the endoscopist will compare the size of the polyp to the size of the snare loop to estimate and document the size of the polyp(s). However, with the size of a polyp being a major indicator of malignant potential as well as an indicator of appropriate polypectomy technique and surveillance intervals, a device with which to take and document accurate and objective measurements of polyps during colonoscopy holds the potential for health benefits. In addition to having a potential clinical benefit for each patient in terms of polypectomy and surveillance intervals, as an objective indicator of polyp size, this technique also holds promise for use in future studies that evaluate polyp size as an indicator of potential malignancy (or future malignancy) and for use by national clinical guidelines committees who may utilize these objective data to update future screening and surveillance recommendations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Micro-Tech Endoscopic Gauge | Experimental | Use of the device during screening or surveillance colonoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Micro-Tech Endoscopic Gauge | Device | Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel | Scale of 1-10, with 1 being the easiest and 10 being the hardest | At the time of the procedure |
| Mean Score Indicating Ease of Extending and Retracting the Device | Scale of 1-10, with 1 being the easiest and 10 being the hardest | At the time of of the procedure |
| Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement | Scale of 1-10, with 1 being the easiest and 10 being the hardest | At the time of the procedure |
| Mean Score Indicating Ease of Use in Taking a Picture That Included the Measuring Device and Polyp in Order to Photo-document the Measurement Reading | Scale of 1-10, with 1 being the easiest and 10 being the hardest | At the time of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Difference in Size of Polyp | The size of the polyp measured by the device will be subtracted from the size of the polyp as measured by the standard, device-free optical visualization. | At the time of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Pochapin, MD | New York School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New York University School of Medicine | New York | New York | 10016 | United States |
All of the individual participant data collected during the trial, after deidentification will be shared. Requests will be directed to mark.pochapin@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Data will become available beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal will have access to the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Micro-Tech Endoscopic Gauge | Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Micro-Tech Endoscopic Gauge | Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel | Scale of 1-10, with 1 being the easiest and 10 being the hardest | Posted | Count of Participants | Participants | At the time of the procedure |
|
|
24 hours after 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 | Micro-Tech Endoscopic Gauge | Use of the device during screening or surveillance colonoscopy Micro-Tech Endoscopic Gauge: Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Pochapin, MD | NYU Langone Health | 212-263-9177 | Mark.Pochapin@nyulangone.org |
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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 21, 2020 | May 18, 2021 | 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Mean Score Indicating Ease of Extending and Retracting the Device | Scale of 1-10, with 1 being the easiest and 10 being the hardest | Posted | Mean | Standard Error | score on a scale | At the time of of the procedure |
|
|
|
| Primary | Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement | Scale of 1-10, with 1 being the easiest and 10 being the hardest | Posted | Mean | Standard Error | score on a scale | At the time of the procedure |
|
|
|
| Primary | Mean Score Indicating Ease of Use in Taking a Picture That Included the Measuring Device and Polyp in Order to Photo-document the Measurement Reading | Scale of 1-10, with 1 being the easiest and 10 being the hardest | Posted | Mean | Standard Error | score on a scale | At the time of the procedure |
|
|
|
| Secondary | Mean Difference in Size of Polyp | The size of the polyp measured by the device will be subtracted from the size of the polyp as measured by the standard, device-free optical visualization. | Posted | Mean | Standard Error | mm | At the time of the procedure |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 0 |
| 23 |
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| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |