Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients

NCT01576120 | Completed Phase 1 Results

• 1 other identifier: RD-207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.

Conditions

Crohn's Disease

Keywords

Known, active Crohn's disease; Iieocolonic or colonic involvement; proven patency of the GI tract

Outcome Measures

Primary Outcomes (1)

• • Evaluate the Effectiveness of the PillCam COLON 2 Bowel Prep Regimen in Crohn's Disease Patients

  effectiveness of the PillCam COLON 2 bowel prep regimen in Crohn's Disease patients will be evaluated by the folloiwng: • Bowel preparation cleansing level assessment The duration of the procedure in this study is 1 day of colon preparation and 1 day of Capsule Endoscopy (CE) procedure. 5-9 days after the CE procedure a follow up call to the subjects will be conducted.

  The end points and outcomes measures will be evaluated within 4 months from end of enrollment

Study Arms (2)

bowel prep regimen first boost 6 oz. and second boost 3 oz.

EXPERIMENTAL

4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 6 oz. SuPrep administered and 3hrs later 3 oz. SuPrep was administered if needed depends on the capsule progress in the GI

Other: bowel prep regimen first boost 6 oz. and second boost 3 oz.

bowel prep regimen first boost 3 oz. and second boost 6 oz.

EXPERIMENTAL

4L of PEG split into two doses:1.on the evening before the exam 2.on the morning of exam day.Upon SB Detection 3 oz. SuPrep administered and 3hrs later 6 oz. SuPrep was administered if needed depends on the capsule progress in the GI

Other: bowel prep regimen first boost 3 oz. and second boost 6 oz.

Interventions

bowel prep regimen first boost 6 oz. and second boost 3 oz. OTHER

Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)

bowel prep regimen first boost 6 oz. and second boost 3 oz.

bowel prep regimen first boost 3 oz. and second boost 6 oz. OTHER

Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)

bowel prep regimen first boost 3 oz. and second boost 6 oz.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 years of age and above
• Subjects who are determined by their physician to have active Crohn's disease based on at least one of the following tests which were performed in the past 3 months :
• Colonoscopy
• Capsule endoscopy of the small bowel or colon
• Other radiology tests
• Clinical symptoms with elevated positive inflammatory markers ;ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, or fecal alpha-1 antitrypsin
• Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 3 months prior to enrollment
• Subject is able and agrees to sign the Informed Consent Form

You may not qualify if:

• Subject has dysphagia
• Subject has congestive heart failure
• Subject has renal insufficiency
• Subject has cirrhosis
• Subject is known or is suspected to suffer from intestinal obstruction
• Subject has known previous stricture/obstruction of the SB or colon
• Chronic use of laxatives
• Subject has a cardiac pacemaker or other implanted electro medical device.
• Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
• Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
• Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
• Subject has any condition, which precludes compliance with study and/or device instructions.
• Subject suffers from life threatening conditions
• Subject is currently participating in another clinical study
• Subject has known slow gastric emptying time or GI transit time.

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (2)

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342, United States

Location

Dayton Gastroenterology

Beavercreek, Ohio, 45440, United States

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Ravit Peled | Clinical Trials Manager
• Organization: Given Imaging

Ravit.peled@covidien.com

+972 (4) 909-7894

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2012
• First Posted: April 12, 2012
• Study Start: March 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 8, 2019
• Results First Posted: October 9, 2014

Record last verified: 2014-10

Locations

US (2)