PillCam SB3 Capsule- Feasibility Study

Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients

Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy.

Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease.

Preparation for procedure will include 12 hours fasting prior to the capsule ingestion

Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.

Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured

Study Overview

• Status: Completed
• Conditions: Small/Large Bowel
• Intervention / Treatment: Device: capsule endoscopy

Detailed Description

• Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
• Study design- Feasibility study
• Number of subjects- Up to 200
• Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
• No of centers- 4
• Duration of enrollment up to 12 months from IRB approval to enroll study patients
• Duration of follow-up 1 week after capsule procedure.
• Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Jerusalem, Israel
    • Bikur Holim medical center
• Romania
  • Bucharest, Romania
    • University Hospital
• Spain
  • Pamplona, Spain
    • Servicio de Digestivo Hospital de Navarra
• Sweden
  • Lund, Sweden
    • Skane University Hospital, Lund University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

1. Patient age is ≥ 18 years old,
2. Patients with history suggestive and /OR symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy,
3. Patient and/or legal guardian is able and agrees to sign the Informed Consent Form

Exclusion criteria

1. Patient has dysphagia,
2. Patient is known or is suspected to suffer from intestinal obstruction,
3. Patient has known previous stricture/obstruction of the SB or colon,
4. Patient has a cardiac pacemakers or other implanted electro medical devices, 5. 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,

6. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule, 7. Patient 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, 8. Patient has any condition, which precludes compliance with study and/or device instructions, 9. Patient suffers from life threatening conditions, 10. Patient is currently participating in another clinical study, 11. Patient has known slow gastric emptying time

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: capsule endoscopy	Device: capsule endoscopy; capsule endoscopy procedure; Other Names: CE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians	precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians	up to 6 months from end of recruitment

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Samuel Adler, Prof, Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): October 1, 2012

Study Registration Dates

• First Submitted: September 7, 2011
• First Submitted That Met QC Criteria: September 11, 2011
• First Posted (Estimate): September 13, 2011

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 29, 2019
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: small bowel disease
• Other Study ID Numbers: RD-304