Polyp Measurement Device

NCT03856255 | Terminated Results FDA Device

• 1 other identifier: 18-02047
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (1)

• Mean Difference in Size of Polyp

  At the time of the procedure

Study Arms (1)

Micro-Tech Endoscopic Gauge

EXPERIMENTAL

Use of the device during screening or surveillance colonoscopy

Device: Micro-Tech Endoscopic Gauge

Interventions

Micro-Tech Endoscopic Gauge DEVICE

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

Micro-Tech Endoscopic Gauge

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals age 50-85 years old, who require an outpatient screening or surveillance colonoscopy
• Ability to give consent

You may not qualify if:

• Pregnancy
• Inflammatory bowel disease

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Mark Pochapin, MD
• Organization: NYU Langone Health

Mark.Pochapin@nyulangone.org

212-263-9177

Study Officials

• Mark Pochapin, MD

  New York School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2019
• First Posted: February 27, 2019
• Study Start: June 24, 2019
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: June 14, 2021
• Results First Posted: June 14, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available beginning 3 months and ending 5 years following article publication
• Access Criteria: Researchers who provide a methodologically sound proposal will have access to the data.

Locations

US (1)