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Polyp Measurement Device

A Pilot, Single-centered, Single-arm, Feasibility Study Evaluating a Polyp Measurement Device in Patients Undergoing Screening or Surveillance Colonoscopy

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03856255
Enrollment
36
Registered
2019-02-27
Start date
2019-06-24
Completion date
2020-06-01
Last updated
2021-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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

DEVICEMicro-Tech Endoscopic Gauge

Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
Yes

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

MeasureTime frameDescription
Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working ChannelAt the time of the procedureScale of 1-10, with 1 being the easiest and 10 being the hardest
Mean Score Indicating Ease of Extending and Retracting the DeviceAt the time of of the procedureScale 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 MeasurementAt the time of the procedureScale 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 ReadingAt the time of the procedureScale of 1-10, with 1 being the easiest and 10 being the hardest

Secondary

MeasureTime frameDescription
Mean Difference in Size of PolypAt the time of the procedureThe 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

ArmCount
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
Total23

Baseline characteristics

CharacteristicMicro-Tech Endoscopic Gauge
Age, Continuous63 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 typeEG000
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

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

Time frame: At the time of of the procedure

ArmMeasureValue (MEAN)Dispersion
Micro-Tech Endoscopic GaugeMean Score Indicating Ease of Extending and Retracting the Device1.43 score on a scaleStandard Error 0.21
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

Time frame: At the time of the procedure

ArmMeasureValue (MEAN)Dispersion
Micro-Tech Endoscopic GaugeMean Score Indicating Ease of Use in Placing the Measuring Device Adjacent to the Polyp in Order to Determine a Measurement2.62 score on a scaleStandard Error 0.4
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

Time frame: At the time of the procedure

ArmMeasureValue (MEAN)Dispersion
Micro-Tech Endoscopic GaugeMean Score Indicating Ease of Use in Taking a Picture That Included the Measuring Device and Polyp in Order to Photo-document the Measurement Reading2.17 score on a scaleStandard Error 0.87
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

Time frame: At the time of the procedure

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Micro-Tech Endoscopic GaugeNumber of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel21 Participants
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.

Time frame: At the time of the procedure

ArmMeasureValue (MEAN)Dispersion
Micro-Tech Endoscopic GaugeMean Difference in Size of Polyp0.28 mmStandard Error 0.21

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026