Clinical trials: Video Capsule Endoscopy
Small Bowel Bleeding
A Post Market Trial Assessing the Accuracy of Normal Mode Reading vs. ProScan Reading With the NaviCam SB System. This is a Comparison of Retrospectively Obtained Capsule Endoscopy Videos With a New AI Reading Tool; no New Interventions Will be Completed.
NaviCam ProScan is an artificial intelligent (AI) assisted reading tool designed to aid small bowel capsule endoscopy reviewers in decreasing the time to review capsule endoscopy images for adult patients in whom the capsule…
- Trial name
- PROCEED (NCT07633847)
- Testing
- Video capsule endoscopy, Phase II = Data analysis by Independent Readers, Phase III = Data Analysis by Expert Readers
- Where
- 3 sites in United States
- Volunteers
- 92 people
- Sponsor
- AnX Robotica Corp.
Crohn's Disease
Development of Niv Score of Capsule Endoscopy in Patients With Crohn's (CECDAIic)
Hypothesis This study is designed as an integral part of the development of a new CE score for Crohn's disease. The SB (small bowel) CD (Crohn's Disease)Niv score (CECDAI) is an established and validated CD score for SB…
- Trial name
- NCT01793376
- Volunteers
- 30 people
- Sponsor
- Medtronic - MITG
Colonic Diseases
PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
To see if PillCam COLON will demonstrate diagnostic yield >80% in detecting significant colonic pathologies when compared to colonoscopy in the target population.
- Trial name
- MA-53 (NCT00604162)
- Testing
- PillCam COLON, Standard colonoscopy
- Where
- 7 sites in France, Germany and 3 more
- Volunteers
- 332 people
- Sponsor
- Medtronic - MITG
Crohn's Disease
The Effect on Mucosal Healing With Pentasa Sachet in Mild to Moderate Active "Drug: Crohn's Disease"
The purpose of this study is to visualize the healing effect on mucosal lesions with Pentasa Sachet 4g in patients with mild to moderate active small bowel CD by video capsule endoscopy.
- Trial name
- NCT00245505
- Testing
- Mesalazine (Mesalamine)
- Where
- Sweden
- Volunteers
- 3 people
- Sponsor
- Ferring Pharmaceuticals
Colorectal Lesions
Evaluation of Capsule Endoscopy With PillCam® Colon 2 in Visualization of the Colon
This pilot, multi center study will establish the effectiveness of Given PillCam® Platform with the PillCam® Colon 2 Capsule as demonstrated by the identification of subjects with polyps, compared to standard colonoscopy.
- Trial name
- NCT01269372
- Testing
- PillCam Colon 2, Colonoscopy
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Crohn Disease
Clinical Study Comparing PillCam® Crohn's Capsule Endoscopy to Ileocolonoscopy (IC) Plus MRE for Detection of Active CD in the Small Bowel and Colon in Subjects With Known CD and Mucosal Disease.
This study will evaluate the efficacy of capsule endoscopy (CE) versus ileocolonoscopy (IC) plus MRE for detection of active Crohn's disease (CD) in the small bowel in subjects with known CD and mucosal disease.
- Trial name
- BLINK (NCT03241368)
- Testing
- Capsule Endoscopy
- Where
- 26 sites in United States, Austria and 1 more
- Volunteers
- 187 people
- Sponsor
- Medtronic - MITG
Intestinal Abnormalities
Diagnosis of Intestinal Motility by Image Analysis Using Capsule Endoscopy
Conventional intestinal manometry is the current gold standard for the evaluation of intestinal motility, and identifies patterns of intestinal dysmotility.
- Trial name
- NCT01085513
- Testing
- PillCam SB2
- Where
- 6 sites in United States, Belgium and 3 more
- Volunteers
- 143 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Colonic Diseases
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
The purpose of this study is to evaluate the effect of a modified Prep and procedure on colon cleansing level and capsule excretion rate.
- Trial name
- NCT00885209
- Where
- 5 sites in Spain
- Volunteers
- 127 people
- Sponsor
- Medtronic - MITG
Colorectal Cancer Screening
Colon Capsule Endoscopy (CCE) Versus Computed Tomographic Colonography (CTC) in the Identification of Colonic Polyps in a Screening Population.
The primary objective of this multicenter, prospective, randomized study is to assess the diagnostic yield of Colon Capsule Endoscopy (CCE) versus Computed Tomographic Colonography (CTC) in a screening population.
- Trial name
- TOPAZ (NCT02754661)
- Testing
- COLON Capsule endoscopy, Computed Tomographic Colonography
- Where
- 13 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Any Gastric Condition Which Requires Capsule Endoscopy
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
The purpose of this study is to support development of PillCam Endoscopy System applications.
- Trial name
- NOISE (NCT02775708)
- Testing
- Pillcam endoscopy system
- Where
- 2 sites in Germany, Spain
- Volunteers
- 53 people
- Sponsor
- Medtronic - MITG
Known Crohn Disease Subjects
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
- Trial name
- NCT01942720
- Testing
- Capsule endoscopy and Ileocolonoscopy tests
- Where
- 15 sites in United States
- Volunteers
- 74 people
- Sponsor
- Medtronic - MITG
Colonoscopy, Endoscopy
Evaluation of PillCam® Colon 2 Capsule Endoscopy Regimen
The purpose of the study is to test the effect of a bowel preparation and boosts regimen on PillCam® procedure, colon cleanliness and capsule excretion time.
- Trial name
- NCT01185002
- Testing
- PillCam® COLON 2 procedure using MgC boosts, PillCam® COLON 2 procedure using Suprep boosts, PillCam® COLON 2 procedure using reduced dose of Suprep boosts
- Where
- 7 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Chronic Inflammatory Small Bowel Disease, Crohn's Disease
PillCam SBC System Functionality in Established and Suspected IBD Patients
This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.
- Trial name
- PIANO (NCT02742714)
- Testing
- PillCam SBC system
- Where
- 5 sites in Israel, Italy and 1 more
- Volunteers
- 54 people
- Sponsor
- Medtronic - MITG
Healthy Volunteers
Video Capsule Endoscopy to Investigate the Safety and Tolerability of Lumiracoxib in the Small Bowel
This study is designed to investigate the potential differences in GI safety and tolerability in the small bowel between lumiracoxib, conventional non-selective NSAID (naproxen) with a proton pump inhibitor (omeprazole), or…
- Trial name
- NCT00350155
- Testing
- Lumiracoxib
- Where
- 2 sites in Germany, United Kingdom
- Volunteers
- 150 people
- Sponsor
- Novartis
Intestinal Disease, Inflammatory Bowel Diseases
Validation of CapsoVision CapsoCam® SV-3 Capsule Endoscopy System
To validate an updated version of CapsoCam® SV-3 Endoscopy System brand name CapsoCam Plus™) with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate…
- Conditions
- Intestinal Disease, Inflammatory Bowel Diseases, Crohn Disease, Ulcer
- Trial name
- NCT04573959
- Testing
- SV-3 Capsule Endoscopy
- Where
- United States
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Capso Vision, Inc.
Inflammatory Bowel Diseases
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic standard workup.
- Trial name
- MACCS (NCT00434551)
- Where
- 8 sites in Australia
- Volunteers
- 119 people
- Sponsor
- Medtronic - MITG
Celiac Disease
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
- Trial name
- NCT00555737
- Testing
- Capsule Endoscopy
- Where
- 5 sites in United States, Finland and 1 more
- Volunteers
- 102 people
- Sponsor
- Medtronic - MITG
Pill Capsule Endoscopy Completion Rates
Study of Metoclopramide in Small Bowel Capsule Endoscopy
Patients undergoing small bowel capsule endoscopy will be randomized into 3 study groups to either receive 5 mg of metoclopramide, 10 mg of metoclopramide, or a placebo 30 minutes prior to swallowing the Pill Cam.
- Trial name
- NCT01630109
- Testing
- Metoclopramide
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Ascension Health
Colorectal Cancer Screening
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure
This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.
- Trial name
- NCT02481219
- Testing
- PillCam® COLON 2 procedure-CONTROL, Senna tablets, PEG
- Where
- 6 sites in United States
- Volunteers
- 122 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Colonic Diseases
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Night Procedure
The purpose of this study is to evaluate the effect of the night procedure in regards to colon cleansing level and capsule excretion rate.
- Trial name
- NCT00951587
- Testing
- PillCam™ (Capsule Endoscopy)
- Where
- 2 sites in Germany
- Volunteers
- 49 people
- Sponsor
- Medtronic - MITG