Evaluating a Treatment Effect in Patients With FBSS Using an Electronic Nose: a Pilot Study

NCT ID: NCT04469738

Last Updated: 2021-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-12

Study Completion Date

2021-03-27

Brief Summary

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This study is an experimental single-center pilot study investigating Volatile Organic Compounds patterns in exhaled breath during on and off states of SCS, in patient with Failed Back Surgery Syndrome.

Detailed Description

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Conditions

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Failed Back Surgery Syndrome

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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SCS off

Group Type EXPERIMENTAL

SCS is switched off

Intervention Type DEVICE

Spinal cord stimulator is switched off for 12 hours

SCS on

Group Type EXPERIMENTAL

SCS is switched on

Intervention Type DEVICE

Spinal cord stimulator is functioning

Interventions

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SCS is switched off

Spinal cord stimulator is switched off for 12 hours

Intervention Type DEVICE

SCS is switched on

Spinal cord stimulator is functioning

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.

Exclusion Criteria

* Patients with a diagnosis of cancer.
* Patients with major psychiatric problems.
* Patients with an underlying respiratory disease.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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the eNose company

UNKNOWN

Sponsor Role collaborator

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Moens Maarten

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maarten Moens, Prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Universitair Ziekenhuis Brussel

Locations

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Universitair Ziekenhuis Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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NOSE

Identifier Type: -

Identifier Source: org_study_id

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