Clinical trials: sponsored by 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
Crohn's Disease
Evaluation of a PillCam Colon Bowel Preparation Regimen in Crohn's Disease Patients
The proposed study is designed to evaluate Pillcam regimen in Crohn's disease patients, using the PillCam Colon system.
- Trial name
- RD-207 (NCT01576120)
- Testing
- bowel prep regimen first boost 6 oz. and second boost 3 oz., bowel prep regimen first boost 3 oz. and second boost 6 oz.
- Where
- 2 sites in United States
- Volunteers
- 40 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
PillCam® Platform With the PillCam Crohn's Disease Capsule
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients…
- Trial name
- NCT01631435
- Testing
- Pillcam colon capsule and PillCam™ Prep Procedure, Ileocolonoscopy
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Medtronic - MITG
Small/Large Bowel
PillCam SB3 Capsule- Feasibility Study
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…
- Trial name
- NCT01433042
- Testing
- capsule endoscopy
- Where
- 4 sites in Israel, Romania and 2 more
- Volunteers
- 225 people
- Sponsor
- Medtronic - MITG
CRC Screening
Evaluation of Capsule Endoscopy With PillCam® COLON 2 in Visualization of the Colon
This study was design to establish the effectiveness of PillCam® Platform with the PillCam® COLON 2 capsule as demonstrated by the identification of subjects with polyps as compared to optical colonoscopy.
- Trial name
- NCT01372878
- Testing
- PillCam® COLON 2 procedure, Colonoscopy
- Where
- 17 sites in United States, Israel
- Volunteers
- 884 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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
Gastrointestinal Bleeding
Evaluation of Gastric Juice Samples During Standard Gastroscopy Procedure
Development of a new diagnostic detection tool for gastrointestinal bleeding.
- Trial name
- NCT01267318
- Where
- Israel
- Volunteers
- 5 people
- Sponsor
- Medtronic - MITG
Gastro Esophageal Reflux Disease
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance (Encore)
Study Hypothesis: This study is designed as an integral part of the development of new or improved features or components of the Bravo® pH Monitoring System and may serve verification and validation purposes.
- Trial name
- NCT01788085
- Testing
- Bravo pH monitoring procedure
- Where
- Israel
- 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
Bowel Diseases
Evaluation of the PillCam™ Colon Capsule -2 System
The purpose of this study is to evaluate the ability of the PillCam Colon Capsule 2 to detect polyps and other pathologies in the colon.
- Trial name
- NCT00884624
- Where
- 5 sites in Israel
- Volunteers
- 255 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
Colonic Diseases, and Large Bowel Diseases
Evaluation of PillCam™ Colon 2 in Visualization of the Colon
Evaluate accuracy of PCCE-2 in detecting patients with colonic polyps as compared to conventional colonoscopy.
- Trial name
- NCT01063231
- Testing
- PillCam™ (Capsule Endoscopy) Colon 2 capsule
- Where
- 8 sites in Belgium, France and 5 more
- Volunteers
- 119 people
- Sponsor
- Medtronic - MITG
Crohn Disease
Evaluation of Small Bowel Colon Capsule for Bowel Visualization in Crohn's Disease Patients
Study Hypothesis: It is estimated that by re-programming some of the PillCam COLON2 system parameters it can serve as tool for visualizing both small bowel and colon.
- Trial name
- SBC-CD (NCT01233310)
- Where
- 4 sites in Israel
- Volunteers
- 26 people
- Sponsor
- Medtronic - MITG
Barrett's Esophagus, Gastroesophageal Reflux Disease
PillCam® ESO 2 in Esophageal Pathologies
Study Hypothesis: PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis.
- Trial name
- MA-76 (NCT00885469)
- Where
- 10 sites in United States
- Volunteers
- 101 people
- Sponsor
- Medtronic - MITG
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
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
Colonic Diseases
Evaluation of the PillCam Colon Capsule Endoscopy (PCCE) Preparation and Procedure
To evaluate the effect of a modified preparation and procedure on colon cleansing level
- Trial name
- NCT00604292
- Where
- 3 sites in Germany
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Upper GI Bleeding
Evaluation of PillCam With Blood-Sensing Feature: A Feasibility Study
1. Primary Scientific Objective Collect human clinical data to sustain the development of blood detection sensor and optimize its algorithm and parameters Preliminary evaluation of blood detection performances in human. 2.
- Trial name
- NCT01448382
- Testing
- PillCam® capsule with Given PillCam® Platform
- Where
- Israel
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG