Effectiveness of Stiffening Wire in Colonoscopy With Pre-Owned Colonoscopes

August 2, 2011 updated by: Cornwall Regional Hospital

Effectiveness of a Proprietary Intraluminal Stiffening Wire in Decreasing Procedure Time and Improving Cecal Intubation Rate With Pre-owned Colonoscopes; a Randomized, Controlled Trial

The study aims to determine whether a proprietary, FDA approved stiffening wire improves the efficiency of colonoscopy (that is, decreases the duration of the procedure) and/or enables complete visualization of the colon in a greater proportion of cases (than when the procedure is performed without it) with old, used colonoscopes.

Colonoscopes are designed with a delicate balance between stiffness and flexibility. Stiffness helps to prevent curling (looping) of the colonoscope in those sections of the colon that are not fixed to the wall of the abdominal cavity and flexibility enables successful negotiation of bends or flexures in the colon. As colonoscopes age, they lose stiffness and this makes it very challenging to advance the colonoscope all the way to the cecum (the upper end of the colon). Even when the cecum is successfully reached, it may take an inordinately long time.

In Jamaica, most endoscopists (General Surgeons and Gastroenterologists) use older, pre-owned colonoscopes imported from the USA, because the average patient and local health insurance companies cannot bear the level of fees that would enable cost recovery for new equipment.

The stiffening wires (in two grades of stiffness) used in this study are passed through the biopsy channel of the colonoscope only after its tip has passed the upper end of the descending colon and entered the transverse colon. The device is safe when used as recommended by the manufacturers (and approved by the FDA), and does not appear to increase risk over and above the risk of colonoscopy with the unassisted colonoscope. Although the device clearly improves the stiffness of the colonoscope, there is no research evidence that it actually works in practice, either to improve cecal intubation rate or to decrease procedure time. It is therefore also unclear whether the possible benefit of using the device is achieved if introduced at the first opportunity allowed by the manufacturers or only after difficulty is encountered with the unassisted colonoscope.

In this study, patients are randomly assigned to one of 3 "interventions". One group has colonoscopy performed with the colonoscope alone and the wires are only introduced if there is difficulty advancing the colonoscope after it has passed into the transverse colon ("difficulty" defined as failure to advance the tip of the colonoscope after 5 minutes). In the 2nd and 3rd groups, the assigned wire will be introduced as soon as the colonoscope enters the transverse colon and is removed if "difficulty" is encountered, as defined above. The different phases of colonoscopy will be timed with a stop watch and when a sufficient number of patients has been accrued, the investigator will be able to compare the time it takes to complete the procedure with and without the wires as well as the proportion of cases in which the cecum was reached with and without the assistance of the wires.

Study Overview

Status

Status

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

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.
112

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

  • Jamaica
    • St. James
      • Montego Bay, St. James, Jamaica
        • Mobay Hope Medical 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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults 18 years and older having screening or diagnostic colonoscopy

Exclusion Criteria:

  • Previous hysterectomy
  • Previous radical prostatectomy
  • Clinical presentation or imaging study suggesting presence of lesion that could obstruct passage of colonoscope

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: Diagnostic
  • 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: Stiffening wire only if difficulty
Colonoscopy is performed with the unassisted colonoscope. The stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Experimental: Stiffening wire #1 transverse colon
Colonoscopy is started with the unassisted colonoscope. Stiffening wire #1 is introduced on entry of the tip of the colonoscope into the transverse colon.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Experimental: Stiffening wire #2 transverse colon
Colonoscopy is started with the unassisted colonoscope. Stiffening wire #2 is introduced on entry of the tip of the colonoscope into the transverse colon.
Device: Colonoscope stiffening device
Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The "standard" stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the "firm" wire replaces the "standard" wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Standard" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the "standard" wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "firm" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical
Device: Colonoscope stiffening device
"Firm" stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the "standard" wire and so on until cecal intubation is achieved or the procedure is abandoned.
Other Names:
  • ZUTR-141700 (Standard) and ZUTR-161700 (Firm) by Zutron Medical

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
Time Frame
Cecal intubation
Time Frame: 10 months
10 months

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
Time Frame
Time to cecal intubation
Time Frame: 10 months
10 months

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.
Cornwall Regional Hospital

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.
MoBay Hope Medical Center, Jamaica

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: Jeffrey M East, MD, Cornwall Regional Hospital

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.
December 1, 2009

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.
January 1, 2011

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.
January 1, 2011

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).
April 29, 2010

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.
April 30, 2010

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.
May 3, 2010

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.
August 3, 2011

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.
August 2, 2011

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.
July 1, 2011

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.
  • JE-1

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.

Clinical Trials on Colonoscopy

Clinical Trials on Colonoscope stiffening device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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