Balloon Colonoscopy for Incomplete Colonoscopy

NCT00935857 | Terminated Results

• 1 other identifier: STU00008540
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticulosis

Keywords

Balloon Enteroscopy; Looping

Outcome Measures

Primary Outcomes (1)

• Complete Colonoscopy to the Cecum

  Number of patients with a complete colonoscopy to the cecum

  Day of Procedure

Secondary Outcomes (2)

• Time (Minutes) to Cecum

  Day of Procedure

• Procedural Complications

  7 days post procedure

Study Arms (2)

Balloon Colonoscopy

EXPERIMENTAL

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

Device: Single Balloon Colonoscopy

Standard Colonoscopy

ACTIVE COMPARATOR

Colonoscopy using a standard adult colonoscope

Device: Standard Colonoscopy

Interventions

Single Balloon Colonoscopy DEVICE

Use of the single balloon enteroscopy system (enteroscope and balloon-overtube) to complete colonoscopy.

Balloon Colonoscopy

Standard Colonoscopy DEVICE

Use of the standard adult colonoscope to complete colonoscopy.

Standard Colonoscopy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Diverticulum

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination due to interim analysis showing statistical difference; single operator.

Results Point of Contact

• Title: Rajesh N. Keswani
• Organization: Northwestern University

raj-keswani@northwestern.edu

312-695-5620

Study Officials

• Rajesh N Keswani, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: July 7, 2009
• First Posted: July 9, 2009
• Study Start: April 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: September 25, 2014
• Results First Posted: September 25, 2014

Record last verified: 2014-09

Locations

US (1)