Clinical trials: sponsored by Medtronic
Peripheral Artery Disease
FlowMet-R Blood Flow Measurement for the Diagnosis of Peripheral Artery Disease and Critical Limb Ischemia
Non-randomized, multi-center, longitudinal study of healthy subjects and subjects with PAD who are scheduled for ABI, TBI, and either Duplex Ultrasound or Angiographic assessments in a vascular clinic.
- Trial name
- NCT04120610
- Testing
- FlowMet-R, ABI, TBI
- Where
- 5 sites in United States
- Volunteers
- 195 people, healthy volunteers welcome
- Sponsor
- Medtronic Endovascular
Nasal Airway Obstruction
Novapak Prospective Observational Clinical Trial
The Novapak study is a prospective, observational, multi-site, non-controlled, non-randomized, case-series, with a 2 week and 1-month follow-up in adults undergoing nasal/sinus surgery with Novapak Nasal Sinus Packing and Stent…
- Trial name
- Novapak (NCT05747014)
- Testing
- Novapak Nasal Sinus Packing and Stent
- Where
- 4 sites in United States, Canada
- Volunteers
- 86 people, healthy volunteers welcome
- Sponsor
- Medtronic Surgical Technologies
Type 1 Diabetes
Evaluation of Meal Gesture Dosing in Adults With Type 1 Diabetes
The purpose of this feasibility study is to evaluate subject safety of using the Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing) within the AHCL system in adult subjects with type 1 diabetes in a…
- Trial name
- NCT04964128
- Testing
- MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)
- Where
- Israel
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Medtronic MiniMed, Inc.
Anesthesia
Evaluation of Bispectral Index (BIS™) and Levels of Sedation With Common Inhalational Anesthetics in Healthy Volunteers (OLIVER)
To investigate the relationship between BIS™ and inhaled anesthetics across a wide range of anesthetic concentration and hypnotic states, and to provide evidence to support BIS™ performance in use with Isoflurane, Sevoflurane and…
- Trial name
- OLIVER (NCT04602546)
- Testing
- BIS Complete Monitoring System
- Where
- 3 sites in United States
- Volunteers
- 211 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Anesthesia
Bispectral Index and Levels of Sedation With Propofol With/Without Remifentanil in Healthy Volunteers (SONORA)
The purpose of this study is investigate the relationship between BIS™ and propofol with/without remifentanil across a wide range of hypnotic states.
- Trial name
- SONORA (NCT04466384)
- Testing
- BIS
- Where
- United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Capnography
A Comparison of Capnography Sampling Lines
This study evaluates the performance of eight (8) cleared capnography carbon dioxide (CO2) sampling filterlines during patient simulated scripted activities when connected to a Medtronic (MDT) dual parameter monitor.
- Trial name
- FRS (NCT03554629)
- Testing
- Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- 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
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
CIED Related Infection
World-wide Randomized Antibiotic Envelope Infection Prevention Trial
Medtronic , Inc. is sponsoring the World-wide Randomized Antibiotic Envelope Infection Prevention Trial (WRAP-IT), a randomized, prospective, multi-center, single blinded, post-market, interventional clinical study.
- Trial name
- WRAP-IT (NCT02277990)
- Testing
- TYRX™ Absorbable Antibacterial Envelope
- Where
- 181 sites in United States, Austria and 23 more
- Volunteers
- 7,075 people, healthy volunteers welcome
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
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
Diabetes Mellitus, Type 1
SWITCH - Sensing With Insulin Pump Therapy to Control HbA1c
The primary objective of this study is to evaluate whether the patients with Type 1 diabetes mellitus in sub-optimal glycemic control can achieve better glycemic control by using the Medtronic MiniMed Paradigm® REAL-Time Pump…
- Trial name
- SWITCH (NCT00598663)
- Testing
- insulin pump with continuous glucose sensing (Paradigm Real-Time Insulin Pump System), insulin pump and blinded continuous glucose sensing (Paradigm Real-Time insulin pump)
- Where
- 8 sites in Austria, Denmark and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Medtronic MiniMed, Inc.
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
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
Type 1 Diabetes
Obtain a Good Blood Glucose Control With the Paradigm Real Time System
In this study, subjects with insufficient metabolic control despite optimized basal-bolus injection regimens were randomily assigned to either the Mini- Med Paradigm REAL-Time insulin pump (PRT), an insulin pump that can receive…
- Trial name
- RTD (NCT00441129)
- Testing
- Minimed paradigm Real Time Sytem, Minimed Paradigm 512/712 Insulin pump
- Where
- 8 sites in France
- Volunteers
- 115 people, healthy volunteers welcome
- Sponsor
- Medtronic MiniMed, Inc.
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
Healthy, Hypoxia
Controlled Acute Hypoxia Study Comparing Pulse Oximetry to Arterial Blood Samples During Motion
To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
- Trial name
- NCT02247765
- Testing
- Arterial line, Motion
- Where
- 2 sites in United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Healthy Volunteers
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.
- Trial name
- NCT02265783
- Testing
- Nellcor USB Pulse Oximeter Monitor Interface Cable
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
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
Obesity
Use of Radiofrequency Ablation for RGB Salvage
The present study will assess the feasibility of using endoscopic radiofrequency ablation (RFA) to treat the gastric pouch and stoma with the intent to cause tissue contraction and decreased compliance after a failed Roux-en-Y…
- Trial name
- NCT01910688
- Testing
- RFA treatment
- Where
- 2 sites in United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Focus of the Study is Measuring Respiratory Rate
Respiration Rate V2.0 in Healthy Volunteers
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for…
- Trial name
- NCT01804062
- Where
- United States
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG