Clinical trials: sponsored by Medtronic - MITG
Inguinal Hernia
Comparison of Self-Fixating vs Non-Fixating Hernia Mesh
The purpose of this study is to determine if self-fixating polyester mesh will have lower incidence of chronic postoperative pain and recurrence than non-fixating polyester mesh when used for laparoscopic inguinal hernia repair.
- Trial name
- NCT02062775
- Testing
- Use of self-fixating mesh for inguinal hernia repair, Use of non-fixating mesh for inguinal hernia repair, Absorbable tacks may be used in hernias >2cm
- Where
- United States
- Volunteers
- 285 people
- Sponsor
- Endeavor Health
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
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
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
Bowel Diseases
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
The purpose of this study is to evaluate the effect of the PCCE preparation and procedure on colon cleansing level and excretion rate.
- Trial name
- NCT00885235
- Where
- 4 sites in United States
- Volunteers
- 40 people
- 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
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
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
Upper Gastrointestinal Hemorrhage
A Pilot and Feasibility Study to Evaluate Capsule Endoscopy
This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO 2 Capsule in: Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI) tract, 2) identifying the anatomic…
- Trial name
- MA-79 (NCT00974701)
- Testing
- PillCam ESO2
- Where
- 2 sites in Hong Kong, Israel
- Volunteers
- 50 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
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
Gastro Esophageal Reflux Disease
Development of Applications of the Bravo® pH Monitoring System and Evaluation of Its Performance
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 The study population…
- Trial name
- NCT01503476
- Testing
- Bravo® pH Monitoring System
- Where
- Israel
- Volunteers
- 170 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
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
Healthy
Feasibility Study to Evaluate the Performance of Flocculation-Adsorption System for Colon Cleansing Enhancement
The purpose of this study is to demonstrate feasibility of enhancing colon cleansing.
- Trial name
- RD-400 (NCT01370759)
- Testing
- Cleaning capsule
- Where
- Israel
- Volunteers
- 81 people, healthy volunteers welcome
- 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
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
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