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PillCam SB3 Capsule- Feasibility Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Given Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT01433042
First received: September 7, 2011
Last updated: December 15, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention
Small/Large Bowel
Device: capsule endoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients

Resource links provided by NLM:


Further study details as provided by Given Imaging Ltd.:

Primary Outcome Measures:
  • Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians [ Time Frame: up to 6 months from end of recruitment ] [ Designated as safety issue: No ]
    precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians


Enrollment: 225
Study Start Date: August 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: capsule endoscopy Device: capsule endoscopy
capsule endoscopy procedure
Other Name: CE

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01433042

Locations
Israel
Bikur Holim medical center
Jerusalem, Israel
Romania
University Hospital
Bucharest, Romania
Spain
Servicio de Digestivo Hospital de Navarra
Pamplona, Spain
Sweden
Skane University Hospital, Lund University
Lund, Sweden
Sponsors and Collaborators
Given Imaging Ltd.
Investigators
Principal Investigator: Samuel Adler, Prof Given Imaging Ltd.
  More Information

No publications provided

Responsible Party: Given Imaging Ltd.
ClinicalTrials.gov Identifier: NCT01433042     History of Changes
Other Study ID Numbers: RD-304
Study First Received: September 7, 2011
Results First Received: February 12, 2013
Last Updated: December 15, 2013
Health Authority: Israel: Ethics Commission

Keywords provided by Given Imaging Ltd.:
small bowel disease

ClinicalTrials.gov processed this record on November 25, 2014