NCT02860195

Completed

Evaluation of the Sensitivity of a Transdermal Device to Mon...

Assistance Publique Hopitaux De Marseille Source

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Other study identifiers

Sponsor study identifier

2016-12

Secondary identifiers

2016-A00729-42

REGISTRY · ANSM

Study Type

interventional

Actual enrollment (reported)

6

Locations

0 countries

Sites

N/A

Timeline

Study Start

September 2016

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2017

Actual (reported)

Study Completion

September 2017

Actual (reported)

Brief Summary

A non invasive transdermal sensor device was developed by the Im2Np laboratory to determine the presence of vapor of alcohol in insensible perspiration. One of possible application would be a continuous and non invasive monitoring of drinking behavior. To investigate the validity of this method, it's necessary to compare Transdermal Alcohol Concentrations results obtained by this new device with Blood Alcohol Concentrations and breath Alcohol Concentrations provided by reference methods. The purpose of this study is to identify the kinetic of alcohol concentration in blood, exhaled air and sweat after alcohol ingestion.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 6 participants
Study completion date: September 2017
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
July 27, 2016
Actual (reported)
First Posted
August 9, 2016
Actual (reported)
Study Start
September 2016
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2017
Actual (reported)
Study Completion
September 2017
Actual (reported)

Last Updated: October 2, 2017
Status Verified: September 2017
Last Update Submitted: September 28, 2017

Conditions

The Sweat Alcohol Concentration

Outcome Measures

Primary Outcomes (1)

The determination of ethanol in the plasma
blood samples
6 months

Secondary Outcomes (2)

measures in the exhaled air
6 months
sweat alcohol concentration
6 months

Study Arms (1)

healthy volunteers

EXPERIMENTAL

Other: oral dose of alcoholDevice: alcotestBiological: blood samplesDevice: Transdermal monitor

Interventions

oral dose of alcoholOther

healthy volunteers

alcotestDevice

healthy volunteers

blood samples

Eligibility Criteria

Age18 Years - 40 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Male or female 18-40 years, age-matched (+ 3 years)
Caucasian

Sponsors & Collaborators

Assistance Publique Hopitaux De Marseille
Otherlead

MeSH Terms

Interventions

EthanolBlood Specimen Collection

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsSpecimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

Catherine GEINDRE
Assistance Publique Hopitaux De Marseille
STUDY DIRECTOR
OLIVIER BLIN
ASSISTANCE PUBLQIUE HOPITAUX DE MARSEILLE
PRINCIPAL INVESTIGATOR

Enrollment

6 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: DIAGNOSTIC
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

July 27, 2016

First Posted

August 9, 2016

Study Start

September 2016

Date type not reported

This date has not been verified as actual or estimated.

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Biological

healthy volunteers

Transdermal monitorDevice

healthy volunteers

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

BMI: 19 to 28 kg/m2

No smoking or light smoker (\<5 cig/d)

Moderate consumer of alcohol (3-14 drinks/week), with the intoxicated experience

You may not qualify if:

Subjects with addiction to toxic or alcohol (MINI Questionnaire)
Positive individuals in search of drugs and toxic
Anxiety or depressive subjects (IASTA Questionnaires and BDI)

Contact the study team to confirm eligibility.

Primary Completion

March 2017

Actual (reported)

Study Completion

September 2017

Actual (reported)

Last Updated

October 2, 2017

Record last verified: 2017-09

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02860195
Data provider: ClinicalTrials.gov
Source updated: 2017-10-02
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:29:58 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (1)

healthy volunteers

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record