PillCam® Platform With the PillCam Crohn's Disease Capsule

NCT ID: NCT01631435

Last Updated: 2019-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2014-02-28

Brief Summary

This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).

Detailed Description

This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:

Visit 1; Screening visit

• Informed consent process
• screening for eligibility to participate in the study
• Inclusion/exclusion criteria
• Small bowel patency test
• Demographic data
• Pregnancy test
• General medical history

Visit 2; PillCam® Crohn's capsule ingestion

• PillCam® CD bowel preparation
• Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
• Ileocolonoscopy with intubation of terminal ileum

Follow up period (5-9 days following visit 2)

• CE Follow up telephone contac

Conditions

Crohn's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

bowel prep regimen

Each study subject will undergo a bowel preparation followed by a PillCam procedure.

Group Type: OTHER

Pillcam colon capsule and PillCam™ Prep Procedure

Intervention Type: OTHER

PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.

Ileocolonoscopy

Intervention Type: DEVICE

Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure

• Ileocolonoscopy with intubation of terminal ileum

Interventions

Pillcam colon capsule and PillCam™ Prep Procedure

PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.

Intervention Type: OTHER

Ileocolonoscopy

Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure

• Ileocolonoscopy with intubation of terminal ileum

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Subject ages 18-75 years, inclusive

2. Subject has known CD and signs and symptoms of active disease including one of the following:

• Chronic diarrhea
• Chronic abdominal pain
• Rectal bleeding

3. Subject has at least one of the following within three months of enrollment:

• Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin)
• Anemia (hemoglobin level below normal reference range)
• Hypoalbuminemia (albumin below normal reference range)
• Weight loss

4. Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.

5. Subject agrees to sign consent form

Exclusion Criteria

1. Indeterminate Colitis

2. Ulcerative Colitis

3. Antibiotic Associated Colitis

4. Stool positive for Ova &Parasite and for Clostridium difficile toxin within 3 months of enrollment

5. Other known infectious cause of increased symptoms

6. Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.

7. Definite long stricture seen on radiological exam.

8. Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment

9. Suspected GI stricture, followed by Pillcam Patency study or other imaging study that could not prove patency of the GI tract.

10. Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.

11. Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.

12. Subjects with known or suspected delayed gastric emptying

13. Subjects with known or suspected delayed Small bowel motility

14. Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.

15. Subject has Type I or Type II Diabetes.

16. Subject has any allergy or other known contraindication to the medications used in the study.

17. Subject has any condition, which precludes compliance with study and/or device instructions.

18. Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.

19. Concurrent participation in another clinical trial using any investigational drug or device.

20. Subject suffers from a life threatening condition.

21. Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Debbra Helper, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University, Indianapolis , USA

Locations

IU School of Medicine - Gastroenterology

Indianapolis, Indiana, United States

Countries

United States

Other Identifiers

MA-206

Identifier Type: -

Identifier Source: org_study_id