A Feasibility Study of Virtopsy With Tissue Sampling in B... | NCT03877900

Studies
A Feasibility Study of Virtopsy With Tissue Sampling in Besancon University Hospital

NCT03877900

Sponsor

Centre Hospitalier Universitaire de Besancon

Status

Completed

Last Update Posted

Oct 5, 2020Actual

Enrollment

26Actual

Phase

Not provided

Conditions

Stillbirth and Fetal Death
Termination of Pregnancy
Neonatal Death

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2019Actual

Primary Completion Date

Mar 6, 2020Actual

Completion Date

Mar 6, 2020Actual

First Submitted Date

Mar 14, 2019

First Submission Date that Met QC Criteria

Mar 14, 2019

First Posted Date

Mar 18, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2020

Last Update Posted Date

Oct 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Day

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

1 Month

Standard Ages

Child

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marion AUBER LENOIR, MD	CHU Besançon	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU Besancon		Besançon		25030	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24288400	Background	Addison S, Arthurs OJ, Thayyil S. Post-mortem MRI as an alternative to non-forensic autopsy in foetuses and children: from research into clinical practice. Br J Radiol. 2014 Apr;87(1036):20130621. doi: 10.1259/bjr.20130621.
8888168	Background	Brookes JA, Hall-Craggs MA, Sams VR, Lees WR. Non-invasive perinatal necropsy by magnetic resonance imaging. Lancet. 1996 Oct 26;348(9035):1139-41. doi: 10.1016/S0140-6736(96)02287-8.

ID	Term
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases
D003643	Death

ID	Term
D050497	Stillbirth
D005313	Fetal Death
D066087	Perinatal Death