ThoracoscopyCAVITNCT02966847
Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery
A study testing CBCT acquisition and Anesthesia and surgery in people with Thoracoscopy, run by Rennes University Hospital at 1 site in France.
Trial summary
In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Thoracoscopy
- What is being tested?
- CBCT acquisition and Anesthesia and surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 May 2017to 22 Mar 2019
- Phase
- Interventional
- 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
Who may be able to join
- Age greater than or equal to 18;
- patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
- Complete preoperative assessment;
- Patient receiving information about the protocol who did not indicate his/her opposition to participate;
- Patient covered by a social insurance system
Who cannot join
- Reoperation (history of ipsilateral thoracic surgery);
- Inability to achieve or obtain a single-lung ventilation during surgery;
- Adult subject to legal protection (trusteeship, guardianship);
- Person deprived of liberty.
Trial locations and contacts
1 site in 1 country.
About this study
In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.
Read the detailed description
The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.
- Conditions
- Thoracoscopy
- Being tested
- CBCT acquisition, Anesthesia and surgery
- Keywords
- Video assisted thoracoscopy, Cone beam computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT acquisitionProcedure or surgery
Also called Artis Zeego System®
Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
Anesthesia and surgeryProcedure or surgery
The anesthesia and surgery will take place according clinical routine practice
| Study group | Role | What they receive |
|---|---|---|
| CBCT Acquisition | Experimental | The anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars. Receives: Procedure: CBCT acquisition; Procedure: Anesthesia and surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of CBCT
Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.
Measured: the day following the acquisition
Secondary outcomes (3)
Feasibility of CBCT
Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.
Measured: At the end of the surgery
Assessment of global image quality
Assessment of image quality is based on an "open label" interpretation of CBCT images by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)
Measured: the day following the acquisition
Assessment of image quality of lesions
Assessment of image quality depending on the type of lesion and their location. Interpretation of CBCT images are performed by two senior surgeons who score images from 0 (uninterpretable) to 10 (same quality as CT images)
Measured: the day following the acquisition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start11 May 2017
- Primary completion22 Mar 2019
- Study completion22 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThoracoscopyStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon ROUZE, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966847
- Sponsor's protocol ID
- 35RC16_9838
- Other IDs
- 2016-A01353-48
- Acronym
- CAVIT
- Status last verified
- May 2023
- First submitted
- 15 Nov 2016
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.
PubMed 33588119
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery
- ClinicalTrials.gov ID
- NCT02966847
- Acronym / sponsor ID
- CAVIT / 35RC16_9838
- Conditions
- Thoracoscopy
- Keywords
- Video assisted thoracoscopy, Cone beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 11 May 2017 (actual)
- Primary completion
- 22 Mar 2019 (actual)
- Study completion
- 22 Mar 2019 (actual)
- First posted
- 17 Nov 2016 (estimated)
- 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.
In the coming years, an increase in lung nodule resection is expected, particularly in Video-assisted thoracoscopic surgery (VATS). In some situations, it is necessary to use a device for locating these nodules. Meanwhile, the Cone Beam Computed Tomography (CBCT) is a tool whose use is constantly spreading.
Detailed description
The aim of this study is to evaluate the feasibility of using intraoperative CBCT to develop a new procedure for intraoperative localization of pulmonary nodules in video-assisted thoracoscopic surgery.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBCT Acquisition | Experimental | Procedure: CBCT acquisition, Procedure: Anesthesia and surgeryThe anesthesia and surgery will take place in the usual way. The intervention consists in the CBCT acquisition after the initiation of single-lung ventilation, after the introduction of trocars. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age greater than or equal to 18;
- patient with unique or multiple pulmonary lesions of a size ranging from 5 to 20 mm;
- Complete preoperative assessment;
- Patient receiving information about the protocol who did not indicate his/her opposition to participate;
- Patient covered by a social insurance system
Key exclusion criteria (4 listed)
- Reoperation (history of ipsilateral thoracic surgery);
- Inability to achieve or obtain a single-lung ventilation during surgery;
- Adult subject to legal protection (trusteeship, guardianship);
- Person deprived of liberty.
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 |
|---|---|---|
| CBCT acquisitionAlso: Artis Zeego System®Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device | Procedure or surgery | CBCT Acquisition |
| Anesthesia and surgeryThe anesthesia and surgery will take place according clinical routine practice | Procedure or surgery | CBCT Acquisition |
Primary outcome
Assessment of CBCT
Time frame: the day following the acquisition
Ability to identify the lesion on CBCT images of unventilated lung. CBCT images are interpreted by 2 senior surgeons.
3 secondary outcomes
Feasibility of CBCT
Time frame: At the end of the surgery
Assessment of global image quality
Time frame: the day following the acquisition
Assessment of image quality of lesions
Time frame: the day following the acquisition
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 24 May 2023.
- Results publication: PubMed 33588119Alvarez P, Rouze S, Miga MI, Payan Y, Dillenseger JL, Chabanas M. A hybrid, image-based and biomechanics-based registration approach to markerless intraoperative nodule localization during video-assisted thoracoscopic surgery. Med Image Anal. 2021 Apr;69:101983. doi: 10.1016/j.media.2021.101983. Epub 2021 Jan 30.
- Individual participant dataSharing planned: No
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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.
Simon ROUZE, MD principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBCT acquisition and Anesthesia and surgery in people with Thoracoscopy, run by Rennes University Hospital 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 4 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 24 May 2023. 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?
Assessment of CBCT (time frame: the day following the acquisition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966847, which also lists 1 linked publication.
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 24 May 2023.