Colorectal Cancer
Conditions
Brief summary
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.
Interventions
Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Sponsors
Study design
Eligibility
Inclusion criteria
* Individuals age 50-85 years old, who require an outpatient screening or surveillance colonoscopy * Ability to give consent
Exclusion criteria
* Pregnancy * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel | At the time of the procedure | Scale of 1-10, with 1 being the easiest and 10 being the hardest |
| Mean Score Indicating Ease of Extending and Retracting the Device | At the time of of the procedure | Scale of 1-10, with 1 being the easiest and 10 being the hardest |
| Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement | At the time of the procedure | Scale of 1-10, with 1 being the easiest and 10 being the hardest |
| 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 | At the time of the procedure | Scale of 1-10, with 1 being the easiest and 10 being the hardest |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Difference in Size of Polyp | At the time of the procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | Micro-Tech Endoscopic Gauge |
|---|---|
| Age, Continuous | 63 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 23 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 23 |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Mean Score Indicating Ease of Extending and Retracting the Device
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Time frame: At the time of of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micro-Tech Endoscopic Gauge | Mean Score Indicating Ease of Extending and Retracting the Device | 1.43 score on a scale | Standard Error 0.21 |
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
Time frame: At the time of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micro-Tech Endoscopic Gauge | Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement | 2.62 score on a scale | Standard Error 0.4 |
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
Time frame: At the time of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micro-Tech Endoscopic Gauge | 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 | 2.17 score on a scale | Standard Error 0.87 |
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
Time frame: At the time of the procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Micro-Tech Endoscopic Gauge | Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel | 21 Participants |
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.
Time frame: At the time of the procedure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Micro-Tech Endoscopic Gauge | Mean Difference in Size of Polyp | 0.28 mm | Standard Error 0.21 |