30 closest matches · ranked by relevance
Colonic Diseases
Primary: Number of Participants With Successful Capsule Endoscopies or Standard Colonoscopies — 322; 326 participants
Small Bowel Disease · Inflammatory Bowel Disease
Primary: Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System — 25 participants
Esophageal Lesion
Primary: Number of Participants With Esophageal Lesions Identified Using Capsule Endoscopy — 15 Participants
Capsule Endoscopy
Primary: Completion Rate (Rate at Which Small Bowel is Completely Examined) — 57 Participants
Colorectal Lesions
Primary: Accuracy of the PillCam® Colon 2 Capsule Endoscopy (CE) for Polyps Per Subject - Sensitivity — 83; 50 percentage of sensitivity
Small/Large Bowel
Primary: Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians — 98 percentage of cases
CRC Screening
Primary: Sensitivity and Specificity of PillCam Platform With the PillCam COLON 2 Capsule in Detecting Patients With Polyps ≥6 mm Where OC Considered as the Gold Standard…
Pill Capsule Endoscopy Completion Rates
Primary: Difference in Treatment vs. Placebo in Pill Capsule Completion Rates — 100; 0; 100 percentage of complete capsule studies
Gastro Intestinal Bleeding · Hematemesis · Melena
Primary: Rate of Detection of Bleeding — 11; 11 Participants
Upper Gastrointestinal Bleeding
Primary: Number of Participants Discharged for Outpatient Management of Upper GI Bleeds — 3; 9 Participants
Melena · Gastrointestinal Hemorrhage
Primary: Time to Localization of Bleeding — 21; 16 hours — p=.002
Colorectal Cancer Screening
Primary: Number of Participants With an Actionable Lesion on CCE vs. CTC Confirmed by Optical Colonoscopy — 34; 11 Participants
UGI Bleed · Upper Gastrointestinal Bleeding · Upper Gastrointestinal Bleed
Primary: Sensitivity — 26 Participants
Colonic Diseases · Bowel Diseases
Primary: Accuracy of Detection in Patients With Colonic Polyps - Sensitivity — 89; 100 percentage of sensiivity
Crohn's Disease
Primary: Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within…
Colonoscopy · Incomplete Colonoscopy
Primary: Percentage of Incomplete Long-lasting Colonscopies — 0 % of participants
Colorectal Cancer Screening
Primary: Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE) — 6.8; 16.7; 14.0; 14.6 percentage of particpants
Upper GI Bleeding
Primary: Number of Participants With (Serious) Adverse Event Related to the Medical Device — 0 Participants
Colorectal Cancer · Polyp, Colonic
Primary: The Percent of Colonic Polyps Which Have a Visible Contrast to the Healthy Colonic Mucosa During Colon Capsule Endoscopy (CCE) — 58.3; 66.7; 0; 0 percentage of polyps…
Intestinal Disease · Inflammatory Bowel Disease · Crohn Disease
Primary: Normal vs Abnormal, Overall Impression — 42; 42; 72; 72 participants — p=1.0000
Gastrointestinal Lesions · Signs and Symptoms, Digestive
Primary: GI Mucosal Lesions Change and Clinical Symptoms Using The Gastrointestinal Symptom Rating Scale (GSRS) Score — 2.99; 2.19 GSRS score — p=0.05
Crohn's Disease
Primary: Diagnostic Yield in Suspected Crohn's Patients (CE Prior to IC vs. IC and SBFT) — 97.3; 57.3 percentage of yield — p=<0.0001
Crohn Disease
Primary: Accuracy of CE Versus IC Plus MRE for Detecting Active Crohn's Disease (CD), by Visualizing the Small Bowel and Colon in Subjects With Know CD and Mucosal Disease. — 94…
IBD
Primary: Diagnostic Yield of Magnetic Resonance Enterography (MRE) — 52 % Percentage of Diagnostic yeild
Esophageal Varices
Primary: Aerosol-generating Amount — 8195; 0; 13296; 1483 Particles generated
Outpatients
Primary: Number of Participants With Successful Separation of Capsule and String, and Complete Viewing of Esophagus and Stomach — 25 Participants
Polyps
Primary: Number of Adenomas — 83; 89; 28; 44 First Colonoscopy number of adenomas
Colo-rectal Cancer
Primary: Number of Incidence of Device and Procedure Related Serious Adverse Events (SAE) — 0 Participants
Healthy
Primary: Feasibility of Esophageal Imaging in Subjects Who Successfully Swallow the OCT Capsule in the Primary Care Setting. — 45 Participants
Gastroparesis · Dyspepsia
Primary: Frequency of Contractions at Baseline — 20; 24.6; 23.7 stomach contractions/minute