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Study to Examine Insertion of 2 Colonoscopes Trial


N/A
35 Years
75 Years
Not Enrolling
Both
Colorectal Cancer

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Trial Information

Study to Examine Insertion of 2 Colonoscopes Trial


There will be two arms to the study, the CF-H180 adult colonoscope (Control Arm) and the
Technically Improved Colonoscope. (Control Arm). In this protocol the investigators will
randomize patients to either the adult colonoscope or to the Technically Improved
Colonoscope 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.


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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Outcome Measure:

Intubation of cecum

Outcome Description:

The ability of endoscopist to intubate the cecum with enough control of the tip to abut the appendix or begin to retroflex in the cecum.

Outcome Time Frame:

(day 1) Within time for performance of colonoscopy

Safety Issue:

No

Principal Investigator

Joseph C Anderson, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Connecticut Health Center

Authority:

United States: Institutional Review Board

Study ID:

10-246-1

NCT ID:

NCT01324882

Start Date:

June 2010

Completion Date:

December 2011

Related Keywords:

  • Colorectal Cancer
  • colonoscopy
  • Colorectal Neoplasms

Name

Location
University of Connecticut Health Center Farmington, Connecticut  06360-7106