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

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ClinicalTrials.gov Identifier: NCT03984279
Recruitment Status : Completed
First Posted : June 12, 2019
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Brief Summary:
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.

Condition or disease Intervention/treatment
Patient With Indication of Interventional Percutaneous Diagnostic or Therapeutic Chest-abdomen-pelvic Procedure Under CT Control Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control

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Study Type : Observational
Actual Enrollment : 385 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: 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.
Actual Study Start Date : January 17, 2018
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03984279


Locations
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France
Centre Hospitalier Universitaire
Besançon, France, 25000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Besancon

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Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03984279     History of Changes
Other Study ID Numbers: P/2018/362
First Posted: June 12, 2019    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No