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Significant difference at interim analysis
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balloon Colonoscopy | Experimental | Colonoscopy using the single balloon colonoscopy system (novel endoscope to facilitate difficult colonoscopy). |
|
| Standard Colonoscopy | Active Comparator | Colonoscopy using a standard adult colonoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Balloon Colonoscopy | Device | Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Colonoscopy to the Cecum | Number of patients with a complete colonoscopy to the cecum | Day of Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Time (Minutes) to Cecum | Time, in minutes, until reaching cecum in each arm. | Day of Procedure |
| Procedural Complications | Number of patients with any procedural complications as assessed 7 days after procedure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rajesh N Keswani, MD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
Early termination at 30 patients due to clinically significant differences at midpoint of study.
Patients in the Standard Colonoscopy group could cross-over to the Balloon Colonoscopy group after 20 minutes of procedure time but they were not included in further analysis after cross-over.
Subject recruitment completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | Balloon Colonoscopy | Colonoscopy using the single balloon enteroscope system. |
| FG001 | Standard Colonoscopy | Colonoscopy using a standard adult colonoscope |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
An interim analysis was performed at 30 patients as described in initial protocol. The study was terminated at the interim analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Balloon Colonoscopy | Colonoscopy using the single balloon enteroscope system. |
| BG001 | Standard Colonoscopy | Colonoscopy using a standard adult colonoscope |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Complete Colonoscopy to the Cecum | Number of patients with a complete colonoscopy to the cecum | Per Protocol, Terminated at Interim Analysis | Number | patients | Day of Procedure |
|
|
1 week after completion of endoscopy procedure.
All subjects were called 1 week after completion of procedure to assess for adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Colonoscopy | Patients who are randomized to received standard colonoscopy as initial treatment. |
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Early termination due to interim analysis showing statistical difference; single operator.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rajesh N. Keswani | Northwestern University | 312-695-5620 | raj-keswani@northwestern.edu |
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| ID | Term |
|---|---|
| D004240 | Diverticulum |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Standard Colonoscopy | Device | Use of the standard adult colonoscope to complete colonoscopy. |
|
| 7 days post procedure |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Secondary | Time (Minutes) to Cecum | Time, in minutes, until reaching cecum in each arm. | Mean | Standard Deviation | minutes | Day of Procedure |
|
|
|
| Secondary | Procedural Complications | Number of patients with any procedural complications as assessed 7 days after procedure. | Number | participants | 7 days post procedure |
|
|
|
| 0 |
| 16 |
| 0 |
| 16 |
| EG001 | Single Balloon Colonoscopy | Patients who are randomized to received single balloon colonoscopy as initial treatment. | 0 | 14 | 0 | 14 |
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| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |