Endocuff Enhanced Colonoscopy: Does it Improve Polyp Detection and Make Rectal Retroflexion Unnecessary

March 8, 2024 updated by: Hopital Montfort
The investigators hope that this project will determine if the Endocuff device is a useful adjunct during colonoscopy by optimizing polyp detection and eliminating the need for the painful rectal retroflexion. As such, by improving polyp detection and eliminating the need for rectal retroflexion, it will directly reduce the likelihood of colon cancer and improve patient comfort respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Every day, 73 Canadians are diagnosed with colorectal cancer. This cancer is the third most diagnosed type of cancer in Canada while being the second and third most deadly cancer for men and women respectively. In addition, it accounts for 12% of all cancer diagnoses and cancer deaths for both sexes in 2020. Fortunately, colorectal cancer incidence and mortality rates have been steadily declining in the recent years. This can be attributed to the development of new screening methods and devices assisting in a more reliable identification of polyps as well as removal during colonoscopy. This is essential to prevent cancer as these usually asymptomatic and harmless clusters of atypical cells can turn into cancers, and become fatal if they can progress to a later stage of their development. The Endocuff is a new colonoscopy assisting device designed to aid physicians to maneuver inside the colon, allowing for increased detection of polyps that stay hidden between folds in the colon. By its flexible and hinged arms, the Endocuff is designed to gently flatten the large colonic folds during withdrawal of the colonoscope, bringing the difficult-to-see mucosa to view. The Endocuff also may assist in the view of the rectum, being the last area of the colon and difficult to assess. Usually, a painful procedure called a retroflexion is used to help see this area. However, this pain can limit the evaluation and impact polyp diagnosis in the rectum. In this study, the investigators aspire to answer these following questions: (1) Can the Endocuff improve polyp detection? (2) Can the Endocuff replace the need for retroflexion in the rectum?

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
750

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1K 0T2
        • Hôpital Montfort

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Any patient undergoing a colonoscopy during the study period
  • Procedure being performed by a gastroenterologist (i.e., surgeons are excluded)

Exclusion Criteria:

  • Inflammatory Bowel Disease
  • Hereditary Mixed Polyposis Syndrome
  • Diverticulitis
  • Colonic stricture
  • Toxic Megacolon
  • Previous Colon surgery, excluding appendectomy
  • Radiation therapy to abdomen or pelvis
  • Pregnancy/Lactation
  • Anticoagulant use
  • Suffered stroke or ischemia in previous 3 months
  • Being deemed too risky by investigator
  • FIT positive
  • Poor preparation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Colonoscopy without Endocuff
No Endocuff inserted proximally to colonoscope and use of retroflexion
Experimental: Colonoscopy with Endocuff
Endocuff inserted proximally to colonoscope, no use of retroflexion
Device: Use of Endocuff during colonoscopy
We will be adding the Endocuff device to the proximal end of the colonoscope, adding an additional tool to facilitate the visualization of the difficult-to-see mucosal areas as well as the rectum. There will be no need for retroflexion to evaluate the colon

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Increase in Polyp Detection Rates when using the Endocuff Enhanced Colonoscopy.
Time Frame: 1 hour
Comparing Polyp Detection Rate when using the Endocuff Enhanced Colonoscopy to retrospective conventional colonoscopy.
1 hour
Number of participants endorsing a comfortable procedure when using the Endocuff assisted colonoscopy assessed by Numerical Rating Scale (NRS).
Time Frame: 1 hour
Results of Numerical Rating Scale pain score when evaluating the rectum with the Endocuff.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hopital Montfort

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AFP Innovation Fund

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Philip Hassard, MD, Hôpital Montfort
  • Study Director: Christine-Nadia Compas, CRC, Hôpital Montfort

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 22, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 3, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 14, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22-23-04-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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