MedDataX Logo

Colonoscope Insertion Trial Protocol

NCT ID: NCT01324882

Last Updated: 2017-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This research study is about determining how well a Technically Improved Colonoscope from Olympus works in helping the doctor in guiding the scope through the large bowel or colon. When a doctor performs a colonoscopy he guides or inserts the scope from the rectum to the appendix where the small bowel ends and the large bowel begins. There are points during this insertion where there are turns in the colon which can create a loop in the colonoscope. These loops can stretch the colon and create some discomfort and also require special maneuvers by the nurse or patient to help reduce or minimize the loop. Thus, reducing the looping will make it more comfortable for the patient and more efficient for screening for polyps. The purpose of the study is to examine this colonoscope and compare it to the traditional adult colonoscope (Olympus CF-H180). The investigators hypothesis is that this colonoscope will function better with regard to insertion of the scope from the rectum to the cecum.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the Olympus Technically Improved Colonoscope (Olympus). (Control Arm). In this protocol the investigators will randomize patients to either the adult colonoscope or to the Olympus Technically Improved Colonoscope (Olympus) arm. The name of the arm (CF-H180 adult colonoscope or Technically Improved Colonoscope) will be in a sealed envelope and opened by the nurse. The endoscopist will be blinded to the scope that will be used.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

colonoscopy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Study Arm

This is the group who will have a colonoscopy with the Olympus Technically Improved Colonoscope.

Group Type EXPERIMENTAL

Colonoscopy with Olympus Technically Improved Colonoscope

Intervention Type DEVICE

The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.

Control

This is the group who will have a colonoscopy with the traditional colonoscope Olympus CF-H180.

Group Type ACTIVE_COMPARATOR

Control with standard colonoscope Olympus CF-H180

Intervention Type DEVICE

Standard colonoscopy using the adult scope, Olympus CF-H180.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Colonoscopy with Olympus Technically Improved Colonoscope

The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.

Intervention Type DEVICE

Control with standard colonoscope Olympus CF-H180

Standard colonoscopy using the adult scope, Olympus CF-H180.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Olympus Technically improved colonoscope Olympus CF-H180

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients presenting for outpatient colonoscopy between the ages of 35 and 75 years of age
* The patient population will be open. However, it is known that thin female patients (BMI \< 25) and/or past history of diverticular disease and/or gynecological surgery and men \& women who are tall (6'+) and patients with constipation are usually difficult candidates for a complete colonoscopy (retroflex in the cecum)
* Adequate bowel preparation
* The ability to provide informed consent

Exclusion Criteria

* Women that are pregnant
* Patients with a past history of inflammatory bowel disease
* Patients with a past history of surgical resection (hemicolectomies, etc)
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

UConn Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joseph Anderson

Associate Prof (Adjunct)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joseph C Anderson, M.D.

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1-642-01

Identifier Type: OTHER

Identifier Source: secondary_id

10-246-1

Identifier Type: -

Identifier Source: org_study_id