Comparison of Two Protocols of Optimization of X Ray Radiations in Pediatric Interventional Neuroradiology

NCT ID: NCT02008305

Last Updated: 2017-02-09

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

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-11-30

Brief Summary

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Interventional Neuroradiology replaces surgery. This technology requires various exposition to X rays : number of X rays photographs, radioscopy, distance between patient and detector, speed of acquisition of X-rays photographs, high tension and intensity.

The manipulator must find the right balance between quality of photographs and dose delivered to the patient (optimization).

Children are particularly exposed to these risks of irradiation (sensitivity to X-rays and long life expectancy with risks. So, it is fundamental to optimize the dose delivered during the procedures.

The investigators propose to analyse a study comparing two protocols of optimization of doses. The investigators' hypothesis is that the protocol experimented in this trial allows less radiation of the children, compared to the usual protocol.

Detailed Description

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Conditions

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Occlusion or Malformation of a Cerebral Vessel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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protocol of optimization ALARA

protocol of optimization ALARA protocol of optimization of doses

Group Type EXPERIMENTAL

protocol of optimization ALARA

Intervention Type DEVICE

protocol of opimization Philips

protocol of optimization Philips usual protocol of optimization of doses

Group Type ACTIVE_COMPARATOR

protocol of optimization Philips

Intervention Type DEVICE

Interventions

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protocol of optimization ALARA

Intervention Type DEVICE

protocol of optimization Philips

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* malformation or occlusion of a cerebral vessel requiring interventional Neuroradiology

Exclusion Criteria

* opposition ot the parent(s) to the participation of their child in the trial and/or no social security.
Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michel Piotin

Role: PRINCIPAL_INVESTIGATOR

Fondation Ophtalmologique Adolphe de Rothschild

Locations

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Fondation ophtalmique Adolphe de Rothschild

Paris, Paris, France

Site Status

Countries

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France

Other Identifiers

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SC/DM_MPN_2012-4

Identifier Type: -

Identifier Source: org_study_id

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