Body Interventional procédures With CTAPIR-TDMNCT03984279
Comparison of Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety, Effectiveness, Speed and Radiation in Interventional Chest-abdomen-pelvic Procedures
An observational study of Body Interventional procédures With CT, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial summary
The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Body Interventional procédures With CT
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 17 Jan 2018to 31 Dec 2018
- 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
- Adult, Older adult
Study population: Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Who may be able to join
- adult patients (> 18 years),
- indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Who cannot join
- MRI contra indication
- persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.
The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.
- Conditions
- Body Interventional procédures With CT
- Being tested
- Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT controlOther
Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account
| Study group | Role | What they receive |
|---|---|---|
| Sequentiel group (SEQ) | Not described Receives: Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control | |
| Siral group (SPI) | Not described Receives: Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of major complications
Comparison between the 2 groups
Measured: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
number of targets reached
Comparison between the 2 groups
Measured: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Dose Length Product (DLP)
Comparison between the 2 groups
Measured: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Secondary outcomes (1)
number of controls required to place the needle
Comparison between the 2 groups
Measured: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start17 Jan 2018
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Interventional procédures With CTStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe 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
- Retrospective
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03984279
- Sponsor's protocol ID
- P/2018/362
- Acronym
- APIR-TDM
- Status last verified
- May 2019
- First submitted
- 27 May 2019
- Last updated
- 23 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Study Was to Compare Sequential Fluoroscopy Guidance With Spiral Guidance in Terms of Safety (Number of Major Complications), Effectiveness (Number of Targets Reached), Speed (Procedural Time) and Radiation (DLP) in Interventional Chest-abdomen-pelvic Procedures.
- ClinicalTrials.gov ID
- NCT03984279
- Acronym / sponsor ID
- APIR-TDM / P/2018/362
- Conditions
- Body Interventional procédures With CT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 17 Jan 2018 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 12 Jun 2019 (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.
The purpose of the study was to compare sequential fluoroscopy guidance with spiral guidance in terms of safety (number of major complications), effectiveness (number of targets reached), speed (procedural time) and radiation (DLP) in interventional chest-abdomen-pelvic procedures.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequentiel group (SEQ) | – | Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control |
| Siral group (SPI) | – | Other: Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patient with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Key inclusion criteria (2 listed)
- adult patients (> 18 years),
- indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control
Key exclusion criteria (2 listed)
- MRI contra indication
- persons referred to in Articles L1121-5 to L1121-8 of the French Public Health Code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT controlNot applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account | Other | Sequentiel group (SEQ), Siral group (SPI) |
Primary outcome
number of major complications
Time frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
number of targets reached
Time frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
Dose Length Product (DLP)
Time frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
Comparison between the 2 groups
1 secondary outcome
number of controls required to place the needle
Time frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account
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 23 Jul 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Body Interventional procédures With CT, run by Centre Hospitalier Universitaire de Besancon 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 2 inclusion and 2 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 23 Jul 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?
number of major complications (time frame: All patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control performed on a period of 1 year will be taken into account). The study lists 3 primary outcomes in all. 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 23 Jul 2019.