NCT03506659

Brief Summary

Use of cutaneous electrochemical conductance for preclinical screening of small-caliber nerve fibers

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 24, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2020

Completed
Last Updated

February 28, 2020

Status Verified

February 1, 2020

Enrollment Period

1.9 years

First QC Date

March 15, 2018

Last Update Submit

February 26, 2020

Conditions

Difference, Individual

Outcome Measures

Primary Outcomes (1)

  • Difference of timing for Electrochemical skin conductance

    the investigators will measure the timing between the 4 members for the Electrochemical skin conductance

    3 minutes

Study Arms (2)

Test

ACTIVE COMPARATOR

2000 patients healthy in anesthesiology consultation

Device: SUDO-SCAN Device

Patients

EXPERIMENTAL

2000 patients in pain clinic consultation

Device: SUDO-SCAN Device

Interventions

SUDO-SCAN DeviceDEVICE

Sudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes.

PatientsTest

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult

You may not qualify if:

  • Patients group : Not have a chronic neuropathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ERASME Hospital

Brussels, 1070, Belgium

Location

Study Officials

  • Turgay TUNA, MD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: Parallel group open label Monocentric
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2018

First Posted

April 24, 2018

Study Start

March 1, 2018

Primary Completion

January 30, 2020

Study Completion

January 30, 2020

Last Updated

February 28, 2020

Record last verified: 2020-02

Locations

BE(1)