Colorectal CancerNCT03856255
Polyp Measurement Device
A study testing Micro-Tech Endoscopic Gauge in people with Colorectal Cancer, run by NYU Langone Health at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Micro-Tech Endoscopic Gauge
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jun 2019to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals age 50-85 years old, who require an outpatient screening or surveillance colonoscopy
- Ability to give consent
Who cannot join
- Pregnancy
- Inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: A Pilot, Single-centered, Single-arm, Feasibility Study Evaluating a Polyp Measurement Device in Patients Undergoing Screening or Surveillance Colonoscopy
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
- Being tested
- Micro-Tech Endoscopic Gauge
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-Tech Endoscopic GaugeDevice
Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| Micro-Tech Endoscopic Gauge | Experimental | Use of the device during screening or surveillance colonoscopy Receives: Device: Micro-Tech Endoscopic Gauge |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: At the time of the procedure
Secondary outcomes (1)
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.
Measured: At the time of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start24 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Jun 2020
Why it stopped: Covid-19 restrictions with screening/surveillance colonoscopies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Pochapin, MD, Principal investigator, New York School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03856255
- Sponsor's protocol ID
- 18-02047
- Status last verified
- May 2021
- First submitted
- 25 Feb 2019
- Last updated
- 14 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Single-centered, Single-arm, Feasibility Study Evaluating a Polyp Measurement Device in Patients Undergoing Screening or Surveillance Colonoscopy
- ClinicalTrials.gov ID
- NCT03856255
- Acronym / sponsor ID
- 18-02047
- Conditions
- Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Covid-19 restrictions with screening/surveillance colonoscopies
- Enrolment
- 36 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 27 Feb 2019 (actual)
- Results
- Posted 14 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-Tech Endoscopic Gauge | Experimental | Device: Micro-Tech Endoscopic GaugeUse of the device during screening or surveillance colonoscopy |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals age 50-85 years old, who require an outpatient screening or surveillance colonoscopy
- Ability to give consent
Key exclusion criteria (2 listed)
- Pregnancy
- Inflammatory bowel disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Micro-Tech Endoscopic GaugeUse of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy. | Device | Micro-Tech Endoscopic Gauge |
Primary outcome
Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: At the time of the procedure
Scale of 1-10, with 1 being the easiest and 10 being the hardest
1 secondary outcome
Mean Difference in Size of Polyp
Time frame: At the time of the procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Pochapin, MD principal investigator
New York School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Micro-Tech Endoscopic Gauge in people with Colorectal Cancer, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Indicated Ease of Use in Advancing in Measuring Device Catheter Through the Working Channel (time frame: At the time of the procedure). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2021.