Carolina-ColoWrap® in Colonoscopy Performance and Outcomes Study (C3PO)

March 31, 2015 updated by: ColoWrap, LLC

Efficacy of ColoWrap® Abdominal Binder in Improving Performance and Tolerance of Colonoscopy: a Randomized, Sham-Controlled, Blinded Clinical Trial

Colonoscopy is the gold-standard for colorectal cancer screening in the US. However, complete colonoscopy can be a challenging technical procedure, even for expert gastroenterologists due to variations in patient anatomy, tortuous colons, and looping of the endoscope. Such obstacles can prolong colonoscopy, lead to complications, decrease polyp detection, and impact patient experience and tolerance. The investigators propose to evaluate the efficacy of a new non-invasive abdominal binder (ColoWrap®) in improving the performance and tolerance of colonoscopy by way of a randomized, blinded clinical trial. Eligible participants undergoing colonoscopy at University of North Carolina Hospitals (UNCH) will be recruited for the study and randomized to either the ColoWrap intervention or sham arm. Colonoscopy will be performed per usual operating procedures. The primary outcome will be time to distal extent (cecal intubation time). Secondary outcomes include colonoscopy completion rate, use of ancillary maneuvers, medication usage, procedural difficulty, patient comfort, and operator and assistant fatigue and pain. Efficacy will be assessed on the basis of pairwise comparisons between groups with respect to primary and secondary outcomes.

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.

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.
350

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 Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Unc Hospitals
      • Chapel Hill, North Carolina, United States, 27517
        • UNC Meadowmont Endoscopy Center
      • Hillsborough, North Carolina, United States, 27278
        • UNC Hillsborough Endoscopy Center

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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female adults between the ages of 40 - 80

  • Undergoing a colonoscopy at any of the study locations for:

    i. CRC screening (first colonoscopy or 10 year follow up of negative exam). ii. Surveillance (prior colonoscopy with polyps). iii. Diagnostic colonoscopy performed to evaluate symptoms such as abdominal pain or rectal bleeding.

  • Participants must have completed the full prescribed colonoscopy purgative preparation prior to their procedure, and describe adequate cleansing.
  • For the purposes of informed consent, participants must be able to understand and read English.

Exclusion Criteria:

  • Inability to provide informed consent
  • Active or suspected pregnancy
  • Patients referred due to incomplete colonoscopy or for removal of difficult polyps
  • History of problems with sedation or anesthesia -. Participants electing to be unsedated for colonoscopy
  • Patients undergoing multiple procedures (e.g. upper and lower endoscopy)
  • Previous colon resection surgery
  • Patients with known or suspected diagnosis of inflammatory bowel disease (ulcerative colitis or Crohn's disease)
  • Patients with a history of colorectal cancer or other intra-abdominal malignancy.
  • Patients with open or recent wounds or skin rash on the anterior abdominal wall.
  • History of cirrhosis or ascites
  • Known ventral or umbilical hernia
  • Patients who are medically unstable(American Society of Anesthesiology Class III or above).

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Experimental: ColoWrap Intervention Group
Patients randomized to ColoWrap Intervention Group will have the ColoWrap abdominal binder secured firmly around their lower abdomen just prior to colonoscopy.
Device: ColoWrap
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
Other Names:
  • ColoWrap abdominal binder
  • ColoWrap colonoscopy binder
  • ColoWrap device
  • ColoWrap binder
Sham Comparator: Sham Group
Sham Group will also have a ColoWrap binder placed around their lower abdomen, but it will be placed loosely so no appreciable lower abdominal pressure is generated by the device.
Device: ColoWrap
ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
Other Names:
  • ColoWrap abdominal binder
  • ColoWrap colonoscopy binder
  • ColoWrap device
  • ColoWrap binder

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
Mean colonoscopic insertion time
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Colonoscopic insertion time will be defined as the time from insertion of the colonoscope into the rectum to identification of the base of the cecum
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency of use of ancillary maneuvers
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Binary data indicating individually whether abdominal pressure or patient position change was used during the insertion phase of the procedure will be recorded.
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Frequency of prolonged, difficult cases
Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
The frequency of prolonged, difficult cases. Procedures in which the insertion phase is greater than 20 min will be recorded and indicated as such.
During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Drug and Dosage Required to Complete Procedure
Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Drug and dosage amount required by patient to complete colonoscopy.
During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Colonoscopy Completion Rate
Time Frame: During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Colonoscopy completion rate. Dichotomous outcome indicating if the procedure was incomplete or complete.
During colonoscopy, from time point of insertion of scope into rectum to point in time when scope is removed from rectum
Time to patient discharge
Time Frame: From time point in which scope is removed from patient's rectum following a colonoscopy until the time the patient is discharged from the facility
Time to discharge, defined as the time from withdrawal of the colonoscope to patient discharge from the endoscopy unit.
From time point in which scope is removed from patient's rectum following a colonoscopy until the time the patient is discharged from the facility
Operator perception of patient discomfort
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Immediately following completion of procedure, ColoWrap study assistant will obtain operator perception of patient discomfort during procedure according to the Gloucester score
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Patient Pain, Bloating, and Satisfaction at Discharge
Time Frame: At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility
The ColoWrap study assistant will interview patient just prior to discharge and obtain responses for pain and bloating according to 10-point visual analog scales, and global satisfaction according to a 5-point scale.
At single time point occurring after the colonoscopy, just prior to the patient being discharged from facility
Operator's Assessment of Procedural Difficultly
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Immediately following completion of procedure, the study assistant will obtain the operator's assessment of procedural difficulty and level of physical fatigue according to 5-point scales.
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
Assistant/Technician's Assessment of Musculoskeletal Pain Following Procedure
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
The study assistant will ask the endoscopy technician if they experienced pain during the procedure in any of the following four anatomical sites: lower back, upper back, neck, or upper extremities (right and left shoulder, arm, wrist, hand, fingers). This frequency data will be dichotomous.
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patient Assessment of Intra-Procedural Pain
Time Frame: During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified
For patients undergoing colonoscopy with conscious sedation, the study assistant will also obtain a response for intra-procedural pain, using a validated measure of procedural comfort.
During colonoscopy, from insertion of scope into rectum to point in time when base of cecum is identified

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.
ColoWrap, LLC

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.
University of North Carolina, Chapel Hill

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: Seth D Crockett, MD, MPH, Division of Gastroenterology and Hepatology, University of North Carolina, Chapel Hill, NC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

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.
April 1, 2014

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.
March 1, 2015

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.
March 1, 2015

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).
December 28, 2013

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.
December 30, 2013

First Posted (Estimate)

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.
January 1, 2014

Study Record Updates

Last Update Posted (Estimate)

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.
April 3, 2015

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 31, 2015

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, 2015

More Information

Terms related to this study

Keywords

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.
  • ColoWrap-002

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings