Clinical trials: sponsored by Medtronic - MITG
Newborn, Birth, Preterm
Pulse Oximetry Performance Comparison in Newborns
The overall purpose is to directly compare pulse rate (PR) acquisition and oxygen saturation performance between two pulse oximeters (PO) in newborns.
- Trial name
- NCT06637917
- Testing
- OxySoftN™ Neonatal-Adult SpO2 Sensor with N600X Nellcor™ Patient Monitoring System, LNCS® NEO SpO2 Sensor with RAD-97™ Pulse CO-Oximeter, 1041PTS (or similar) Kendall™ Neonatal Electrodes with IntelliVue MP5 Portable Patient Monitor
- Where
- 3 sites in United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Small Intestine Disease, Small Intestine Cancer
Prospective Collection of PillCam SB3 Videos and Raw Data Files for Future Developments (SODA)
Observational, Multicenter, Post-market, Minimal risk, Prospective data collection of PillCam SB3 videos (including PillCam reports) and raw data files and optional collection of Eneteroscopy reports
- Conditions
- Small Intestine Disease, Small Intestine Cancer, Small Intestinal Ulcer Bleeding, Small Intestine Obstruction
- Trial name
- SODA (NCT03771508)
- Where
- 30 sites in United States
- Volunteers
- 3,712 people
- Sponsor
- Medtronic - MITG
Cerebral Oxygenation, Pediatric ALL
Accuracy Performance Verification of the INVOS™ System in Pediatrics
Prospective, observational, multi-center trial designed to capture calibration and performance evaluation data with the INVOS™ system.
- Trial name
- INCATH (NCT05962905)
- Testing
- Blood sample, INVOS monitoring
- Where
- 5 sites in United States
- Volunteers
- 110 people
- Sponsor
- Medtronic - MITG
Anesthesia
Bispectral Index and End-Tidal Anesthetic Gas Concentration in Pediatric Patients
The purpose of this study is to investigate the relationship between BIS™ values including EEG profile and anesthetic agents in the pediatric population
- Trial name
- BTIGER (NCT04810481)
- Testing
- BIS Complete Monitoring System
- Where
- 8 sites in United States
- Volunteers
- 209 people
- Sponsor
- Medtronic - MITG
Crohn's Disease
Evaluation of Capsule Endoscopy in Patients With Suspected Crohn's Disease
The aim of this study is to validate the ability of Capsule Endoscopy (CE) to accurately diagnose small bowel (SB) Crohns disease in patients with symptoms of abdominal pain and diarrhea.
- Trial name
- MA-51 (NCT00487396)
- Testing
- Capsule Endoscopy
- Where
- 11 sites in United States, Canada and 2 more
- Volunteers
- 98 people
- Sponsor
- 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
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
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
Inflammatory Bowel Diseases
MACCS: Multicenter Australian CE in Patients With Suspected Crohn's Disease Study
This is a prospective study aimed to validate the ability of capsule endoscopy to accurately diagnose small bowel Crohn's disease in symptomatic patients who have a non-diagnostic standard workup.
- Trial name
- MACCS (NCT00434551)
- Where
- 8 sites in Australia
- Volunteers
- 119 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
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
Hernia
Assuring and Defining Outcomes Through Procedural Training Using a Proctorship Model That Collects Patient Outcomes A Single-Arm, Case-Series to Determine the Feasibility of Safe Skills Transfer for Laparoscopic Ventral Hernia Repair Utilizing a Hands-On Proctorship Model.
The objective of the Project ADOPT- Ventral Hernia case-series is to collect clinical outcome data following the completion of a hands-on proctorship training model in laparoscopic ventral hernia repair.
- Trial name
- ADOPT (NCT02238743)
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medtronic - MITG
Barrett Esophagus
HALO Patient Registry: Ablation of Barrett's Esophagus
The HALO Patient Registry is a prospective/retrospective, multi-center patient registry. It provides a framework for treatment and follow-up of patients with Barrett's esophagus (non-dysplastic IM, LGD and HGD).
- Trial name
- NCT00848237
- Testing
- Radiofrequency Ablation (HALO Ablation Systems)
- Where
- United States
- Volunteers
- 5,521 people
- Sponsor
- Medtronic - MITG
Hypoxemia
Oxygen Saturation Alarms in the Neonatal Intensive Care Unit
Infants will be observed in the neonatal intensive care unit for 4 hours. The observer will note the timing of oxygen saturation alarms, staff response, and interrupted staff activities.
- Trial name
- NCT01085539
- Where
- 3 sites in United States
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Subjects With an Existing Intra-arterial Line
Pulse Oximetry_Performance Testing- PCBA-1 (Printed Circuit Board Assembly) NEO/PEDS
To determine accuracy specifications of the pulse oximeter in the NEO/PEDS subject population
- Trial name
- NCT01797250
- Where
- 2 sites in United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Medtronic - MITG
Anesthesia
CARE--Childhood Awareness and Recall Evaluation
The purpose of this study is to describe the incidence of recall or awareness under anesthesia in children aged 5-15 by collecting anesthetic and post-operative follow-up data relating to intra-operative recall during general…
- Trial name
- NCT00308984
- Where
- 3 sites in United States
- Volunteers
- 1,784 people
- Sponsor
- Medtronic - MITG