- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02966847
Assessment of Cone-beam Computed Tomography (CBCT) Assistance to Video-assisted Thoracoscopic Surgery (CAVIT)
May 22, 2023 updated by: Rennes University Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Rennes, France, 35033
- Centre Hospitalier Universitaire de Rennes
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CBCT Acquisition
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.
|
Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
Other Names:
The anesthesia and surgery will take place according clinical routine practice
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
the day following the acquisition
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Feasibility of CBCT
Time Frame: At the end of the surgery
|
Number of patient excluded because of an inability to achieve CBCT acquisition, whatever the reason.
|
At the end of the surgery
|
Assessment of global image quality
Time Frame: the day following the acquisition
|
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)
|
the day following the acquisition
|
Assessment of image quality of lesions
Time Frame: the day following the acquisition
|
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)
|
the day following the acquisition
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon ROUZE, MD, CHU Rennes
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 11, 2017
Primary Completion (Actual)
March 22, 2019
Study Completion (Actual)
March 22, 2019
Study Registration Dates
First Submitted
November 15, 2016
First Submitted That Met QC Criteria
November 15, 2016
First Posted (Estimate)
November 17, 2016
Study Record Updates
Last Update Posted (Actual)
May 24, 2023
Last Update Submitted That Met QC Criteria
May 22, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35RC16_9838
- 2016-A01353-48 (Other Identifier: Id-RCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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