Clinical trials: sponsored by Medtronic - MITG
Small Bowel Disease, Inflammatory Bowel Disease
Evaluation of PillCam® Express Capsule Endoscopy Delivery System
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
- Trial name
- RD-300 (NCT01088646)
- Testing
- PillCam® Express Capsule Endoscopy Delivery System
- Where
- 3 sites in United States
- Volunteers
- 25 people
- Sponsor
- Medtronic - MITG
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
Esophageal Squamous Cell Neoplasia (ESCN)
RFA for Flat Type High-grade and Medium-grade Intraepithelial Squamous Neoplasia
Multicenter, prospective cohort clinical trial in greater China
- Trial name
- REACH (NCT02953418)
- Testing
- Radiofrequency ablation
- Where
- China
- Volunteers
- 34 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
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
Tonsillectomy
A Study of BiZact™ on Children and Adolescents Undergoing Tonsillectomy
The purpose of this study is to assess safety and performance with the use of the BiZact™ device in tonsillectomy procedures in children and adolescents.
- Trial name
- NCT03266094
- Testing
- BiZact™: A bipolar instrument for tonsillectomies
- Where
- 2 sites in United States
- Volunteers
- 60 people
- Sponsor
- Medtronic - MITG
Lung Cancer
superDimension™ Navigation System Version 7.2 With Fluoroscopic Navigation Technology
The purpose of this investigation is to confirm the clinical accuracy of the superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology.
- Trial name
- NCT03585959
- Testing
- superDimension™ Navigation System Version 7.2
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Tonsillectomy
A Study of BiZact™ on Adults Undergoing Tonsillectomy
The purpose of this study is to assess the severity of post-operative pain following the use of the BiZact™ device in adult (≥22 years of age in United States and ≥18 years of age in Europe) tonsillectomy procedures.
- Trial name
- NCT02876575
- Testing
- A bipolar instrument for tonsillectomies
- Where
- 2 sites in United States, Sweden
- Volunteers
- 48 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
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
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
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
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
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
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
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
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
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