Polyp Measurement Device
Primary Purpose
Colorectal Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Micro-Tech Endoscopic Gauge
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Micro-Tech Endoscopic Gauge
Arm Description
Use of the device during screening or surveillance colonoscopy
Outcomes
Primary Outcome Measures
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
Mean Score Indicating Ease of Extending and Retracting the Device
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
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
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03856255
Brief Title
Polyp Measurement Device
Official Title
A Pilot, Single-centered, Single-arm, Feasibility Study Evaluating a Polyp Measurement Device in Patients Undergoing Screening or Surveillance Colonoscopy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Why Stopped
Covid-19 restrictions with screening/surveillance colonoscopies
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
June 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Micro-Tech Endoscopic Gauge
Arm Type
Experimental
Arm Description
Use of the device during screening or surveillance colonoscopy
Intervention Type
Device
Intervention Name(s)
Micro-Tech Endoscopic Gauge
Intervention Description
Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
Primary Outcome Measure Information:
Title
Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel
Description
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Time Frame
At the time of the procedure
Title
Mean Score Indicating Ease of Extending and Retracting the Device
Description
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Time Frame
At the time of of the procedure
Title
Mean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement
Description
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Time Frame
At the time of the procedure
Title
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
Description
Scale of 1-10, with 1 being the easiest and 10 being the hardest
Time Frame
At the time of the procedure
Secondary Outcome Measure Information:
Title
Mean Difference in Size of Polyp
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Pochapin, MD
Organizational Affiliation
New York School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data will become available beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal will have access to the data.
Learn more about this trial
Polyp Measurement Device
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