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PillCam SB3 Capsule- Feasibility Study

NCT01433042 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2019-08-01

Study results available
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Summary

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

Conditions

  • Small/Large Bowel

Interventions

DEVICE

capsule endoscopy

capsule endoscopy procedure

Sponsors & Collaborators

  • Medtronic - MITG

    lead INDUSTRY

Principal Investigators

  • Samuel Adler, Prof · Medtronic - MITG

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • Israel
  • Romania
  • Spain
  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433042 on ClinicalTrials.gov