Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conv... | NCT03241290

Studies
Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice

NCT03241290

Sponsor

University Hospital, Grenoble

Status

Completed

Last Update Posted

Mar 29, 2019Actual

Enrollment

24Actual

Phase

Not provided

Conditions

C.Surgical Procedure

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

ID	Type	Description	Link
2017-A00103-50	Other Identifier	ID RCB

Status Module

Record Verification Date

Mar 2019

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

May 29, 2017Actual

Primary Completion Date

Dec 11, 2018Actual

Completion Date

Jan 30, 2019Actual

First Submitted Date

Jul 3, 2017

First Submission Date that Met QC Criteria

Aug 4, 2017

First Posted Date

Aug 7, 2017Actual

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

Mar 28, 2019

Last Update Posted Date

Mar 29, 2019Actual

Name	Class
Clinical Investigation Centre for Innovative Technology Network	NETWORK

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

THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.

Detailed Description

Expected performance of TED developped technology compared to current equipment (intensifier tube) represent a significant improvement; especially in term of image rendering, irradiation dose reduction and ergonomy.

THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates its ability to be used during Orthopedic, neurological and neurological surgeries.

Patient included in the study will have a surgery during which C-ARM is used. This study doesn't modify the medical care of the patient.

After each surgery, a digital scale of image quality will be filled by the surgeon for each aquisition. Other feedback questionnaires regarding the suitability of the device and the satisfaction of the surgeon will also be completed.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Use of C-ARM ARCO FP-Rk521S		C-ARM ARCO FP-Rk521S is mobile X-ray device that combines a X-Ray sensor and a sensor management software used during surgeries for real-time imaging.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Digital scale of image quality	Digital scale of image quality completed for each acquisition by the surgeon	up to 5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject having signed the non-objection form;
Requiring one of the following surgical procedures:
- Urology: soft ureteroscopy, uteroscopy, sacral neuromodulation, JJ sent placement.
- Orthopedics: vertebroplasty, gamma nail placement, sacro-iliac screw fixation.
- Neurology: spinal surgery

Exclusion Criteria:

Subject who refuse to participate in the study;
Who are under legal protection measure or unable to express their consent (guardianship, curatorship);
Deprived of liberty by judicial or administrative decision.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who undergo surgery (orthopedic, urological or neurological surgery)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Alexandre Moreau-Gaudry, MD, PhD	University Hospital, Grenoble	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Grenoble		Grenoble		38700	France

References Module

Citations

Not provided