A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital (VIRTOPSY+)

October 1, 2020 updated by: Centre Hospitalier Universitaire de Besancon
The aim of this project is to assess the feasibility of a new local post mortem procedure at Besançon University Hospital : Virtopsy+, magnetic resonance (MR) imaging with tissue sampling of the fetus and newborns.

Study Overview

Status

Completed

Conditions

Detailed Description

Minimally invasive autopsy is an alternative for conventional autopsy including post mortem magnetic resonance (MR) imaging and tissues samplings.

Because of the raise of parental refusal of autopsy, we intend to assess the local feasibility of a minimally invasive autopsy approach using post mortem MR imaging of fetuses and newborns in order to detect the major pathological abnormalities and/or to determinate the cause of death.

Study Type

Observational

Enrollment (Actual)

26

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, 25030
        • CHU Besançon

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

No older than 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

  • stillbirth and fetal deaths over 21 weeks of gestation
  • termination of pregnancy over 21 weeks of gestation
  • neonatal death

Description

Inclusion Criteria:

  • stillbirth and fetal deaths over 21 weeks of gestation
  • termination of pregnancy over 21 weeks of gestation
  • neonatal death
  • patient having read the letter of information and signed the consent.

Exclusion Criteria:

  • legal incapacity
  • limited ability to consent
  • lack of parental consent

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: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of virtopsy made completely
Time Frame: month 12
Number of virtopsy made completely (from death until clinical report).
month 12

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Marion AUBER LENOIR, MD, CHU Besançon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

February 28, 2019

Primary Completion (Actual)

March 6, 2020

Study Completion (Actual)

March 6, 2020

Study Registration Dates

First Submitted

March 14, 2019

First Submitted That Met QC Criteria

March 14, 2019

First Posted (Actual)

March 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2020

Last Update Submitted That Met QC Criteria

October 1, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P/2018/394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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