Pilot Study to Evaluate Magnetic Marker Imaging on Diabetic Polyneuropathy and Gastroparesis
NCT01607684 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2012-09-05
Summary
The purpose of this study is to determine whether Magnetic Marker Monitoring is an appropriate opportunity to diagnose and to quantify a suspicious gastroparesis in subjects with diabetic polyneuropathy.
Conditions
- Diabetic Polyneuropathy
- Diabetic Gastroparesis
- Diabetes Mellitus
Interventions
- DEVICE
-
Magnetic Marker Imaging (MMI) with Magma 3D system
Magnetic Marker Imaging (MMI). It comprises of a high-resolution three-dimensional detector system, that detects passively and continuously the magnetic field of a magnetic marker capsule (1g, 6x12mm), which is taken orally by the subject. Changes in frequency, intensity and duration of oscillating marker movements allow us to delineate migrating gastric motor complexes. The Magnetic Marker Imaging takes up to 4 h in which the patient lies in a bed. Short interruptions (e.g. to visit the restroom) during this 4 h period are possible.
Sponsors & Collaborators
-
Martin-Luther-Universität Halle-Wittenberg
lead OTHER
Principal Investigators
-
Thomas Seufferlein, MD · Martin-Luther-Universität Halle-Wittenberg
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2012-01-31
- Primary Completion
- 2012-09-30
- Completion
- 2012-09-30
Countries
- Germany
Study Locations
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