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NCT02985710 · ClinicalTrials.gov registry record · NA
Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan
A NA study of Fabry Disease and Mitochondrial Disease, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT02985710: Completed NA study of Fabry Disease and Mitochondrial Disease, sponsored by Massachusetts General Hospital.
NCT02985710 is a NA study of Fabry Disease and Mitochondrial Disease that has completed, run by Massachusetts General Hospital. The registered enrollment target is 102 participants, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02985710, a NA study of Fabry Disease and Mitochondrial Disease, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can be performed non-invasively, quickly and effectively. The investigators aim to study the use of Sudoscan in rare disease condition associated with small fiber polyneuropathy.
Primary Outcome
The internal software of the Sudoscan will allow analysis of skin conductance in all patients and quantification into normal or abnormal. Correlation of an abnormal conductance measurement with clinical symptoms and signs of small fiber neuropathy will be evaluated for accuracy of Sudoscan measurements
Conditions Studied
Interventions
- PROCEDURE Skin biopsy
- DEVICE Sudoscan
- PROCEDURE QSART
Study Locations (1)
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2016-08 |
| Est. Completion | 2020-08 |
| Phase | NA |
What the finished NCT02985710 record still lists
NCT02985710 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 540-participant average among 32 other Fabry Disease trials with a reported enrollment target (81% lower).
The record links to 4 conditions, with Fabry Disease appearing as the primary indexed condition, and to 3 interventions - of which Skin biopsy is the first listed.
NCT02985710 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02985710 about?
NCT02985710 is a clinical study titled "Assessment of Small Fiber Neuropathy in Rare Diseases Using Sudoscan". Sudoscan™ (Impeto Medical, Paris France) uses electrochemical skin conductance as a novel noninvasive method to detect sudomotor dysfunction. Several small studies have recently shown that Sudoscan use in the assessment of small fiber polyneuropathy (in diabetes mellitus) can be performed non-invasi...
What is the current status of trial NCT02985710?
This trial is currently completed. It is a NA study. The enrollment target is 102 participants. The study started on 2016-08. Estimated completion is 2020-08.
What conditions does trial NCT02985710 study?
This clinical trial studies the following conditions: Fabry Disease, Mitochondrial Disease, Ehlers-Danlos Syndrome, Small Fiber Neuropathy.
What interventions are being tested in trial NCT02985710?
The interventions under investigation include: Skin biopsy (PROCEDURE), Sudoscan (DEVICE), QSART (PROCEDURE).
Who is sponsoring clinical trial NCT02985710?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02985710 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02985710's enrollment target sits among peer trials
102 8th of 32 higher than 25 of 32 other Fabry Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Fabry Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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