Back to results

Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients (RD-207)

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

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

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

About this trial

This is an interventional other trial for Crohn's Disease focused on measuring Known, active Crohn's disease, Iieocolonic or colonic involvement, proven patency of the GI tract

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

• 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.
- Subject is allergic or contraindicated to any of the study medications

Sites / Locations

Atlanta Gastroenterology Associates
Dayton Gastroenterology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

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

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

Arm Description

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

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

Outcomes

Primary Outcome Measures

• 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.

Secondary Outcome Measures

Full Information

NCT ID

NCT01576120

First Posted

April 5, 2012

Last Updated

July 29, 2019

Sponsor

Medtronic - MITG

1. Study Identification

Unique Protocol Identification Number

NCT01576120

Brief Title

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

Acronym

RD-207

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Completed

Study Start Date

March 2012 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic - MITG

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

Detailed Description

Primary Scientific Objective Evaluate the effectiveness of the PillCam COLON 2 Prep Regimen in CD patients. Secondary Objective To evaluate safety of the PillCam™ COLON 2 procedure in CD patients Study Hypothesis Crohn's Disease may be pan-enteric in nature and can affect the small bowel, the colon or both. PillCam COLON 2 may be used for visualization of both SB and colon mucosa in Crohn's Disease patients. However, bowel prep is required in order to evacuate all fecal matter prior to the exam and in order to propel the capsule and complete its traverse through the entire GI track within examination time. The study is designed to evaluate the effectiveness of the prep regimen in terms of transit, excretion and cleansing in CD patients All end points will be evaluated within 4 months from end of enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

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

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1, Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm Description

Arm Title

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

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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)

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

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)

Primary Outcome Measure Information:

Title

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

Description

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: • 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. Subject is allergic or contraindicated to any of the study medications

Facility Information:

Facility Name

Atlanta Gastroenterology Associates

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30342

Country

United States

Facility Name

Dayton Gastroenterology

City

Beavercreek

State/Province

Ohio

ZIP/Postal Code

45440

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs