ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christopher Teshima, University of Alberta
ClinicalTrials.gov Identifier:
NCT01438645
First received: September 14, 2011
Last updated: January 16, 2013
Last verified: January 2013
  Purpose

Colonoscopy is an established technology that enables doctors to obtain live video from inside patients' large intestines, which is essential for the diagnosis of numerous intestinal illnesses. It consists of a long, flexible tube fitted with a light-source and small video camera that transmits the images onto a display monitor. The doctor inserts the scope into the anus, moves it into the rectum and then guides it slowly through the entire colon. Because of the various twists and turns that are part of normal bowel anatomy, advancing the scope through the entire colon is not always successful and can become challenging when the scope forms loops inside the abdomen. Unfortunately, there is no way for the doctor to see the shape of the scope inside the body other than what is seen from the video at its front end, and so navigating the colon relies on instinct accumulated with experience and the "feel" of the scope as loops begin to form. This is important because not only can this loop formation cause pain, but it can also increase the likelihood of an incomplete test. Incomplete tests matter because a major reason for performing colonoscopy is colon cancer screening and surveillance; detecting early cancers at treatable stages and looking for polyps that may be pre-cancerous growths. When colonoscopy does not advance through the entire colon, parts are left unexamined where cancer may develop. A new technology called "ScopeGuide" has been developed that uses magnetic coils embedded within the scope to create a 3D image of the shape of the entire scope inside the body that is projected onto the monitor for the doctor to see. This will show if loops are forming and will provide information about how to eliminate loops once they have formed. In this research study, the investigators will compare colonoscopy with the assistance of ScopeGuide to colonoscopy performed in the standard fashion, to see if ScopeGuide results in more successful procedures that are easier for the doctor and more comfortable for patients.


Condition Intervention
Colonic Neoplasms
Iron Deficiency Anemia
Diarrhea
Device: Olympus ScopeGuide

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: ScopeGuide-assisted Colonoscopy Versus Conventional Colonoscopy for Improved Endoscopic Performance and Enhanced Patient Experience

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Sedation Score [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ] [ Designated as safety issue: Yes ]
    The main efficacy parameter is the amount of sedation used during colonoscopy, expressed as the mean for each group. Since our conscious sedation consists of two different drugs, the doses of each will be converted into a numerical score, such that typical 1 mg dose increments of midazolam and 25 mcg increments of fentanyl will each be assigned a score of '1,' and the two will be added together to give the sedation score.


Secondary Outcome Measures:
  • Patient comfort [ Time Frame: 1 day (immediate outcome assessment after recovery from endoscopy procedure) ] [ Designated as safety issue: No ]
    Patients wil complete a 10 cm visual analogue pain scale (VAS) that will be converted to a numerical score (0-100) with each number representing 1 mm on the 10 cm VAS from 0 at its left extreme (representing 'no pain') to 100 on its right extreme (representing 'unbearably severe pain'). The mean pain score will then be determined for each of the groups.

  • Time-to-cecum [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ] [ Designated as safety issue: No ]
    Time from initial insertion of colonoscope until successful intubation of the cecum (min)

  • Cecal intubation rate [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ] [ Designated as safety issue: No ]
    Proportion of colonoscopy procedures resulting in successful intubation of the cecum.

  • Ancillary maneuvers to facilitate procedure [ Time Frame: 1 day (immediate outcome assessment at time of endoscopy procedure) ] [ Designated as safety issue: No ]
    Number of added maneuvers, including abdominal pressure, repositioning of patient, endoscope loop reduction techniques, used to facilitate advancement of endoscope during procedure.


Enrollment: 250
Study Start Date: September 2011
Study Completion Date: December 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ScopeGuide-assisted colonoscopy
These patients will undergo colonoscopy with the assistance of the Olympus ScopeGuide system.
Device: Olympus ScopeGuide
ScopeGuide-assisted colonoscopy using Olympus CF-H180DL variable-stiffness colonoscopes equipped with ScopeGuide capabilities. ScopeGuide will provide the endoscopist with a 3-dimensional image on the monitor depicting the shape of the colonoscope inside the patient's body as it moves through the colon.
Other Name: Magnetic endoscopy imaging
No Intervention: Conventional colonoscopy
These patients will undergo colonoscopy identical to that in the intervention arm, except with endoscopes lacking the ScopeGuide system.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult patient 18 years or older.
  2. Able to read & write English.
  3. Undergoing colonoscopy at University of Alberta Hospital for any indication.

Exclusion Criteria:

  1. Colonoscopy performed without prior purgative bowel prep.
  2. Patient with active, ongoing lower GI bleeding.
  3. Colonoscopy performed to attempt colonic decompression in acute colonic pseudo-obstruction (Ogilvie's syndrome).
  4. Colonoscopy for which propofol sedation is required.
  5. Inpatient colonoscopy performed by a trainee under staff supervision.
  6. Patient with previous colonic surgery.
  7. Patient with pacemaker or implantable cardioverter-defibrillator (ICD).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438645

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
Christopher Teshima
Investigators
Principal Investigator: Christopher W Teshima, MD FRCPC University of Alberta
  More Information

Publications:
Responsible Party: Christopher Teshima, Assistant Professor, University of Alberta
ClinicalTrials.gov Identifier: NCT01438645     History of Changes
Other Study ID Numbers: ScopeGuide 01
Study First Received: September 14, 2011
Last Updated: January 16, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Colonoscopy
Colon cancer screening

Additional relevant MeSH terms:
Anemia, Iron-Deficiency
Colonic Neoplasms
Anemia, Hypochromic
Anemia
Hematologic Diseases
Iron Metabolism Disorders
Metabolic Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 22, 2014