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N/A N=225 Diagnostic

PillCam SB3 Capsule- Feasibility Study

Small/Large Bowel

Enrolled (actual)
225
Serious AEs
0.4%
Results posted
Feb 2014
Primary outcome: Primary: Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians — 98 percentage of cases

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
capsule endoscopy (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Medtronic - MITG
Primary completion
Oct 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
98

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

Eligibility Criteria

Inclusion criteria

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

Exclusion criteria

  • Patient has dysphagia,
  • Patient is known or is suspected to suffer from intestinal obstruction,
  • Patient has known previous stricture/obstruction of the SB or colon,
  • 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,
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01433042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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