C.Surgical ProcedureNCT03241290
Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice
An observational study of C.Surgical Procedure, run by University Hospital, Grenoble at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2017to 30 Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who undergo surgery (orthopedic, urological or neurological surgery)
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.
Read the 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.
- Conditions
- C.Surgical Procedure
- Keywords
- C-arm, Medical Imaging Device, Radiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital scale of image quality
Digital scale of image quality completed for each acquisition by the surgeon
Measured: up to 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2017
- Study start29 May 2017
- Primary completion11 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical ProcedureStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Responsible party
- Sponsor
- Investigators
- Alexandre Moreau-Gaudry, MD, PhD, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03241290
- Sponsor's protocol ID
- 38RC17.010
- Other IDs
- 2017-A00103-50
- Status last verified
- Mar 2019
- First submitted
- 3 Jul 2017
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03241290
- Acronym / sponsor ID
- 38RC17.010
- Conditions
- C.Surgical Procedure
- Keywords
- C-arm, Medical Imaging Device, Radiological
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- Clinical Investigation Centre for Innovative Technology Network
- Study start
- 29 May 2017 (actual)
- Primary completion
- 11 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 7 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who undergo surgery (orthopedic, urological or neurological surgery)
Key inclusion criteria (5 listed)
- Subject having signed the non-objection form;
- Requiring one of the following surgical procedures:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital scale of image quality
Time frame: up to 5 hours
Digital scale of image quality completed for each acquisition by the surgeon
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
- Clinical Investigation Centre for Innovative Technology Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Active, not recruiting
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C.Surgical Procedure; Cardiac
Recruiting
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
C.Surgical Procedure; Disruption of Wound, Suture
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Moreau-Gaudry, MD, PhD principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of C.Surgical Procedure, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital scale of image quality (time frame: up to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.