Clinical trials: sponsored by Medtronic - MITG
Wearing Comfort
Comfort Check of CO2 Monitoring Cannulas With Oxygen Delivery
The purpose of this test is to evaluate the comfort level of several model configurations of the Smart CapnoLine plus cannula The test focuses on the comfort / discomfort generated by the device, mainly due to tubes around the…
- Trial name
- NCT03109132
- Testing
- Oridion Smart CapnoLine® H Plus with Wedge cannula, Oridion Smart CapnoLine® Plus with Non-Wedge cannula, Experimental sample line Model 3
- Where
- Israel
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Gastroparesis
Clinical Management With SPM System and Validation of the SPM 5 Hour Cutoff in Patients With Symptoms of Gastroparesis
This protocol is designed to validate use of the SPM for diagnosis of delayed gastric emptying in patients with symptoms of gastroparesis and assess impact of a SmartPill study on patient management in the gastroparetic…
- Trial name
- NCT02022826
- Testing
- SmartPill Monitoring System
- Where
- 11 sites in United States
- Volunteers
- 167 people
- Sponsor
- Medtronic - MITG
Type 2 Diabetes, Cardiovascular Disease
DSS: Diabetes Surgery Study - Intensive Medical Management of Type 2 Diabetes, With and Without Gastric Bypass Surgery
The present study is the first stage of a research program whose ultimate goal is to conduct a randomized clinical trial involving type 2 diabetics with BMI from 30.0 to 39.9 kg/m2.
- Trial name
- DSS (NCT00641251)
- Testing
- intensive medical management, RYGB & IMM
- Where
- 5 sites in United States, Taiwan
- Volunteers
- 120 people
- Sponsor
- Medtronic - MITG
Barrett Esophagus
Ablation of Intestinal Metaplasia Containing Dysplasia
The purpose of this study is to determine if the intervention of a 510(k)-cleared endoscopically-guided (Halo Ablation systems), ablation system plus anti-secretory therapy is better than anti-secretory therapy alone in clearing…
- Trial name
- NCT00282672
- Testing
- Ablation System plus anti-secretory medication
- Where
- 19 sites in United States
- Volunteers
- 127 people
- Sponsor
- Medtronic - MITG
Any Gastric Condition Which Requires Capsule Endoscopy
Development of Applications of the ® PillCam Endoscopy System and Evaluation of Their Performance
The purpose of this study is to support development of PillCam Endoscopy System applications.
- Trial name
- NOISE (NCT02775708)
- Testing
- Pillcam endoscopy system
- Where
- 2 sites in Germany, Spain
- Volunteers
- 53 people
- Sponsor
- Medtronic - MITG
Chronic Inflammatory Small Bowel Disease, Crohn's Disease
PillCam SBC System Functionality in Established and Suspected IBD Patients
This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.
- Trial name
- PIANO (NCT02742714)
- Testing
- PillCam SBC system
- Where
- 5 sites in Israel, Italy and 1 more
- Volunteers
- 54 people
- Sponsor
- Medtronic - MITG
Hemodynamic Instability
Hemodynamic Response During Goal Directed Fluid Therapy in the OR
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a…
- Trial name
- NCT02365688
- Testing
- Initial bolus pre-incision
- Where
- United States
- Volunteers
- 18 people
- Sponsor
- Medtronic - MITG
Respiratory Rate
Respiration Rate V2.0 in a Hospital Setting
The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device) in a hospitalized volunteer population when compared to established technologies for…
- Trial name
- NCT01837537
- Where
- United States
- Volunteers
- 90 people
- Sponsor
- Medtronic - MITG
Morbid Obesity
Clinical and Economic Outcomes in Laparoscopic Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Surgery
Study objectives: 1. generate local clinical, health-related quality-of-life and health economic data to evaluate the benefits of two types of minimally invasive weight-loss surgery 2.
- Trial name
- OPTIMIZE (NCT01754194)
- Testing
- Gastric Sleeve Resection, Roux-en-Y Gastric Bypass
- Where
- 18 sites in Germany
- Volunteers
- 293 people
- Sponsor
- Medtronic - MITG
Known Crohn Disease Subjects
Monitoring Disease Activity Using Video Capsule Endoscopy (VCE) in Crohn's Disease (CD) Subjects
This study is designed to evaluate the performance of VCE in the assessment of mucosal inflammation 6 months after the first VCE procedure
- Trial name
- NCT01942720
- Testing
- Capsule endoscopy and Ileocolonoscopy tests
- Where
- 15 sites in United States
- Volunteers
- 74 people
- Sponsor
- Medtronic - MITG
Anesthesia, Neuromuscular Blockade
The Effect of Neuromuscular Blockade on the Composite Variability Index (CVI) During Laryngoscopy
The Bispectral Index (BIS) monitor is used in many operating rooms to provide information to the anesthesiologist about a patient's level of consciousness.
- Trial name
- NCT01450813
- Testing
- Saline 0.06 ml/kg, Rocuronium 0.2 mg/kg, Rocuronium 0.4 mg/kg
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Medtronic - MITG
Obesity
A Prospective, Multi-center, Single-arm Study of the Stomach, Intestinal and Pylorus Sparing (SIPS) Procedure
This study is a prospective, multi-center, single-arm study evaluating the SIPS procedure. Subjects who meet the eligibility criteria will be considered for study participation and will be followed through 12 months.
- Trial name
- NCT02275208
- Testing
- SIPS the stomach, intestinal, pylorus, sparing procedure
- Where
- 7 sites in United States
- Volunteers
- 120 people
- 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
Patient Positioning, Monitoring, Physiologic
An Assessment of the Zephyr BioPatch and Its Ability to Monitor Patient Position
The primary objective of the study is to examine the effectiveness of the Zephyr BioPatch in measuring position changes of a non-patient subject in a lab setting and to examine the effectiveness of the Zephyr BioPatch in…
- Conditions
- Patient Positioning, Monitoring, Physiologic, Pressure Ulcer
- Trial name
- NCT02548624
- Testing
- Zephyr BioPatch
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Non-emergent, Abdominal or Thoracic Procedures
A Post-market Study of the Endo GIA™ Reinforced Reload With Tri-Staple™ Technology
A post-market study of the Endo GIA™ Reinforced Reload with Tri-Staple™ Technology.
- Trial name
- NCT02500537
- Testing
- Endo GIA™ Reinforced Reload with Tri-Staple™ Technology
- Where
- United Kingdom
- Volunteers
- 100 people
- 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
HIV-negative Subjects With Intra-anal Intraepithelial Neoplasia Containing High-Grade Squamous Intraepithelial Lesions
A Trial of Radiofrequency Ablation for Anal Intraepithelial Neoplasia Using the HALO Ablation System
This is a Single-center prospective pilot trial involving up to 22 subjects. This study will assess the feasibility, safety, and efficacy of radiofrequency ablation (RFA) to the anal canal using the FDA cleared HALO Ablation…
- Trial name
- AIN (NCT01970787)
- Testing
- Radiofrequency Ablation (RFA) using the HALO Ablation System
- Where
- United States
- Volunteers
- 22 people
- Sponsor
- Medtronic - MITG
Hemorrhoids, Internal
Safety and Efficacy Study of HET Bipolar System for Treatment of Stage I and Stage II Hemorrhoids
Hemorrhoids are vascular cushions in the anal canal. People are normally born with hemorrhoids, and the presence of hemorrhoids does not imply disease. However, hemorrhoids typically cause symptoms when they enlarge over time.
- Trial name
- NCT01841970
- Testing
- HET Bipolar System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Medtronic - MITG
Anorectal Fistulas
A Prospective, Multi-center, Observational Study of the Use of Permacol™ Collagen Paste to Treat Anorectal Fistulas
This will be a prospective, multi-center, post-market, single arm observational study to collect clinical outcome data on the use of Permacol™ Collagen Paste in the treatment of anorectal fistulas.
- Trial name
- NCT01624350
- Testing
- Permacol collagen paste
- Where
- 10 sites in Denmark, Italy and 1 more
- Volunteers
- 100 people
- Sponsor
- Medtronic - MITG