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Balloon Colonoscopy for Incomplete Colonoscopy

Primary Purpose

Diverticulosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Single Balloon Colonoscopy
Standard Colonoscopy
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diverticulosis focused on measuring Balloon Enteroscopy, Looping

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete

Exclusion Criteria:

  • incomplete colonoscopy due only to poor bowel preparation or inadequate sedation

Sites / Locations

  • Northwestern University Feinberg School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Balloon Colonoscopy

Standard Colonoscopy

Arm Description

Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).

Colonoscopy using a standard adult colonoscope

Outcomes

Primary Outcome Measures

Complete Colonoscopy to the Cecum
Number of patients with a complete colonoscopy to the cecum

Secondary Outcome Measures

Time (Minutes) to Cecum
Time, in minutes, until reaching cecum in each arm.
Procedural Complications
Number of patients with any procedural complications as assessed 7 days after procedure.

Full Information

First Posted
July 7, 2009
Last Updated
September 23, 2014
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00935857
Brief Title
Balloon Colonoscopy for Incomplete Colonoscopy
Official Title
Balloon Colonoscopy Versus Repeat Standard Colonoscopy for Prior Incomplete Colonoscopy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Terminated
Why Stopped
Significant difference at interim analysis
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Patients with a prior incomplete colonoscopy will be enrolled in this study. Patients will be randomized to either an initial repeat attempt with a standard colonoscope or the single balloon enteroscope. If the procedures is unsuccessful, the patient can be crossed-over to the other group. The primary endpoint of the study is a complete colonoscopy.
Detailed Description
Colonoscopy is a well-established practice utilized for the evaluation of lower gastrointestinal tract diseases including, mostly commonly, the screening for colorectal polyps and cancer. Despite improvements in endoscope technology, a significant minority of procedures (up to 10%) can not be safely completed due to a variety of patient factors and technical difficulties. These factors primarily include prior abdominal surgeries resulting in adhesions, severe diverticular disease, inadequate bowel cleansing, and patient discomfort. Options for an incomplete colonoscopy include several endoscopic and non-endoscopic modalities. Non-endoscopic modalities include radiologic studies such as CT/MRI colonography as well as a retrograde barium study. Relative disadvantages of these modalities is the inability to remove colonic polyps, perform biopsies, and in the case of barium studies, a lower sensitivity for pathology. Alternative endoscopic modalities have been described that may assist in successfully completing colonoscopy Of these alternative methods, balloon-overtube assisted colonoscopy is the most promising, but this method has not been studied in a randomized, controlled fashion. In this study, we aim to compare balloon-overtube assisted colonoscopy versus standard colonoscopy for patients with prior incomplete colonoscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulosis
Keywords
Balloon Enteroscopy, Looping

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Balloon Colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy).
Arm Title
Standard Colonoscopy
Arm Type
Active Comparator
Arm Description
Colonoscopy using a standard adult colonoscope
Intervention Type
Device
Intervention Name(s)
Single Balloon Colonoscopy
Intervention Description
Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.
Intervention Type
Device
Intervention Name(s)
Standard Colonoscopy
Intervention Description
Use of the standard adult colonoscope to complete colonoscopy.
Primary Outcome Measure Information:
Title
Complete Colonoscopy to the Cecum
Description
Number of patients with a complete colonoscopy to the cecum
Time Frame
Day of Procedure
Secondary Outcome Measure Information:
Title
Time (Minutes) to Cecum
Description
Time, in minutes, until reaching cecum in each arm.
Time Frame
Day of Procedure
Title
Procedural Complications
Description
Number of patients with any procedural complications as assessed 7 days after procedure.
Time Frame
7 days post procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: prior colonoscopy that was incomplete within the previous 12 months or their two most recent colonoscopies (performed at any time interval) were incomplete Exclusion Criteria: incomplete colonoscopy due only to poor bowel preparation or inadequate sedation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rajesh N Keswani, MD
Organizational Affiliation
Northwestern University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

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Balloon Colonoscopy for Incomplete Colonoscopy

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