PillCam® Platform With the PillCam Crohn's Disease Capsule

Status Completed

Clinical Trial 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).

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01631435
Study type	Interventional
Source	Medtronic - MITG
Contact
Status	Completed
Phase	Phase 1/Phase 2
Start date	June 2012
Completion date	February 2014

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT03815851` - Relationship Between Prophylactic Drainage and Postoperative Complications (PPOI) in Crohn's Patients After Surgery	N/A
Not yet recruiting	`NCT06100289` - A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease	Phase 3
Completed	`NCT02883452` - A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis	Phase 1
Recruiting	`NCT04777656` - Use of Crohn's Disease Exclusion Diet on Top of Standard Therapy Versus Standard Therapy Alone in Unstable Pediatric Crohn's Disease Patients.	Phase 3
Terminated	`NCT03017014` - A Study to Assess Safety and Effectiveness of Adalimumab for Treating Children and Adolescents With Crohn's Disease in Real Life Conditions
Recruiting	`NCT06053424` - Positron Emission Tomography Study of Changes in [11C]AZ14132516 Uptake Following Administration of AZD7798 to Healthy Participants and Patients With Crohn's Disease	Phase 1
Recruiting	`NCT05428345` - A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
Completed	`NCT02508012` - Medico-economic Evaluation of the Therapeutic Drug Monitoring of Anti-TNF-α Agents in Inflammatory Bowel Diseases	N/A
Not yet recruiting	`NCT02858557` - The Effect of Diet on Microbial Profile and Disease Outcomes in Patients With Inflammatory Bowel Diseases	N/A
Terminated	`NCT02882841` - MOlecular BIomarkers and Adherent and Invasive Escherichia Coli (AIEC) Detection Study In Crohn's Disease Patients	N/A
Completed	`NCT03010787` - A First Time in Human Study in Healthy Volunteers and Patients	Phase 1
Completed	`NCT02542917` - Home Versus Postal Testing for Faecal Calprotectin: a Feasibility Study
Terminated	`NCT02417974` - Prevention of Recurrence of Crohn's Disease by Fecal Microbiota Therapy (FMT)	Phase 2
Active, not recruiting	`NCT02316678` - Patient Attitudes and Preferences for Outcomes of Inflammatory Bowel Disease Therapeutics	N/A
Completed	`NCT02154425` - A Multicenter, Postmarketing Study Evaluating the Concentration of Cimzia® in Mature Breast Milk of Lactating Mothers	Phase 1
Completed	`NCT02193048` - Prospective Evaluation of a Scoring System in Patients Newly Diagnosed With Crohn's Disease
Completed	`NCT02265588` - Healthy Approach to Physical and Psychological Problems in Youngsters With IBD (HAPPY-IBD).	N/A
Completed	`NCT02197780` - Head-to-head Comparison of Two Fecal Biomarkers to Screen Children for IBD	N/A
Recruiting	`NCT02395354` - Comparative Prospective Multicenter Randomized Study of Endoscopic Treatment of Stenosis in Crohn´s Disease	N/A
Completed	`NCT01951326` - Efficacy and Safety of Anti-MAP Therapy in Adult Crohn's Disease	Phase 3