Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures (APIR-TDM)

July 22, 2019 updated by: Centre Hospitalier Universitaire de Besancon

Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.

The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

385

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25000
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Description

Inclusion Criteria:

  • adult patients (> 18 years),
  • indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

Exclusion Criteria:

  • MRI contra indication
  • persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Sequentiel group (SEQ)
Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account
Siral group (SPI)
Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of major complications
Time Frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
number of targets reached
Time Frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Dose Length Product (DLP)
Time Frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of controls required to place the needle
Time Frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2018

Primary Completion (Actual)

December 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

May 27, 2019

First Submitted That Met QC Criteria

June 11, 2019

First Posted (Actual)

June 12, 2019

Study Record Updates

Last Update Posted (Actual)

July 23, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • P/2018/362

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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