Clinical trials: sponsored by 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
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
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
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
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
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
Colonic Diseases
Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) Preparation and Procedure
The purpose of this study is to compare two preparation and procedure in order to develop the most optimal capsule procedure in regards to colon cleansing level and capsule excretion rate.
- Trial name
- NCT00885339
- Where
- 4 sites in Italy
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG
Healthy Volunteers
Safety Evaluation of Bowel Cleansing Regimen for PillCam® COLON 2 Capsule Endoscopy
This study is designed to evaluate the safety of a preparation regimen for PillCam® Colon 2 Capsule Endoscopy.
- Trial name
- NCT01575093
- Testing
- The preparation regimen
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Barrett's Esophagus, GERD
Cytosponge Adequacy Study Evaluation II
This study will assess the Minimally Invasive Esophageal Cytology Collection System in Patients with Barrett's Esophagus or GERD Symptoms.
- Trial name
- CASEII (NCT02395471)
- Testing
- Cytosponge™ Cell Collection Device
- Where
- 5 sites in United States
- Volunteers
- 191 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Respiratory Depression
PRediction of Opioid-induced Respiratory Depression In Patients Monitored by capnoGraphY
PRODIGY is a prospective, multi-center, post-market, international cohort study. The primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (RD) episodes in patients…
- Trial name
- PRODIGY (NCT02811302)
- Testing
- Capnostream Monitor
- Where
- 16 sites in United States, France and 5 more
- Volunteers
- 1,495 people
- Sponsor
- Medtronic - MITG
Patients Prescribed Non-invasive Respiratory Monitoring
Trending of Respiratory Rate Using the Nellcor™ Bedside Respiratory Patient Monitoring System
This is an open-label, non-randomized, prospective, descriptive study of the Nellcor™ Bedside Respiratory Patient Monitoring System using the Nellcor™ Respiration Rate parameter and Nellcor™ Adult Respiratory Sensor The study is…
- Trial name
- RespRate (NCT03593603)
- Testing
- Nellcor™ Bedside Respiratory Monitoring System
- Where
- 2 sites in United States
- Volunteers
- 37 people
- Sponsor
- Medtronic - MITG
Telemetry, Patient Monitoring
Surveillance Monitoring as an Alternative to Telemetry
The purpose of the study is to evaluate the impact of surveillance monitoring versus telemetry monitoring on clinical, healthcare economics, resource utilization, and qualitative outcomes.
- Trial name
- NCT03039738
- Testing
- Vital Sync IM & VPMP (Surveillance Monitoring), Telemetry Monitoring
- Where
- United States
- Volunteers
- 206 people
- Sponsor
- Medtronic - MITG
Chronic Inflammatory Small Bowel Disease
GI Fluids Collection for an Ex-Vivo Development of Ingestible Capsule Devices With Real Time Biosensors
Up to 500 subjects undergoing standard endoscopy / pouchoscopy, or having ileostomy or colostomy bags or having an ileal pouch and who meet the eligibility criteria will be enrolled to this study during up to three years at up to…
- Trial name
- CLARINET (NCT02797535)
- Testing
- Endoscopy procedures
- Where
- 2 sites in Israel
- Volunteers
- 66 people
- Sponsor
- Medtronic - MITG
Oxygen Deficiency
Validation of Next Generation Cerebral and Tissue Oximeter
This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
- Trial name
- NCT03128372
- Testing
- Desaturation
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Hernia
A Prospective Study in Patients Undergoing Primary Ventral Hernia Repair Using Parietex™ Composite Ventral Patch
The objective of this study is to assess the recurrence rate following the use of PARIETEX™ Composite Ventral Patch in primary ventral hernia repair by open approach with intra-peritoneal positioning.
- Trial name
- Panacea (NCT01848184)
- Testing
- PARIETEX™ Composite Ventral Patch
- Where
- 10 sites in United States, Belgium and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic - MITG
Inflammatory Bowel Disease, Crohn Disease
Retrospective Collection of PillCam SB Movies
Up to two hundred un-identified PillCam SB movies will be collected from 2 clinical sites, during up to 3 years and transferred to Given Imaging. Demographical data and medical history will be collected.
- Trial name
- OCEAN (NCT02707289)
- Where
- 2 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Medtronic - MITG
Lung Cancer
The EMPrint™ Ablate and RESect Study in Patients With Metastatic Lung Tumors (EMPRESS)
Post market prospective, non-randomized, single-arm, multicenter study, designed to demonstrate dose response of an ablation system using a percutaneous approach in patients with primary, metastatic, or recurrent primary lung…
- Trial name
- EMPRESS (NCT02323854)
- Testing
- Ablation, Surgical Resection
- Where
- 4 sites in United States, Germany
- Volunteers
- 15 people
- Sponsor
- Medtronic - MITG
Delirium, Stroke
Impact of Neuromonitoring During Cardiac Procedures
Through a series of sequential analyses, retrospective database exploration looking for linkages and associations between the use of processed electroencephalogram (EEG) and/or cerebral saturation monitoring and patient outcomes…
- Conditions
- Delirium, Stroke, Acute Kidney Injury
- Trial name
- NCT02681731
- Where
- United States
- Volunteers
- 250,000 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG