PillCam SB3 Capsule- Feasibility Study

NCT01433042 | Completed Results

• 1 other identifier: RD-304
• Study Type: interventional
• Target: 225
• Locations: 4 countries
• Sites: 4

Brief 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

Keywords

small bowel disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

capsule endoscopy

EXPERIMENTAL

Device: capsule endoscopy

Interventions

capsule endoscopy DEVICE

capsule endoscopy procedure

Also known as: CE

capsule endoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (4)

Bikur Holim medical center

Jerusalem, Israel

Location

University Hospital

Bucharest, Romania

Location

Servicio de Digestivo Hospital de Navarra

Pamplona, Spain

Location

Skane University Hospital, Lund University

Lund, Sweden

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Capsule Endoscopy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Director of Clinical affairs
• Organization: Given Imaging Ltd.

Hila.Debby@givenimaging.com

+972-4-9097774

Study Officials

• Samuel Adler, Prof

  Medtronic - MITG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2011
• First Posted: September 13, 2011
• Study Start: August 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: August 1, 2019
• Results First Posted: February 4, 2014

Record last verified: 2013-12

Locations

ES (1); RO (1); SE (1); IL (1)