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

C.Surgical Procedure Clinical Trial

Official title:

Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241290
• Other study ID #: 38RC17.010
• Secondary ID: 2017-A00103-50
• Status: Completed
• Start date: May 29, 2017
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2019
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 30, 2019
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• C.Surgical Procedure

Locations

Country	Name	City	State
France	University Hospital, Grenoble	Grenoble

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Grenoble	Clinical Investigation Centre for Innovative Technology Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Digital scale of image quality	Digital scale of image quality completed for each acquisition by the surgeon	up to 5 hours

External Links

•   Clinical Investigation Centre for Innovative Technology Network website