- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04140474
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules. (SATAN)
September 7, 2021 updated by: University Hospital, Limoges
The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Due to the improvement of screening techniques, the detection of peripheral and isolated lesions is an increasingly frequent situation.
However these SPN cause difficulties in obtaining a sample.
Indeed, current endoscopic techniques remain insufficient in terms of performance.
Moreover, computed tomography-guided percutaneous needle biopsy despite a very good sensitivity has many limitations related to the size of the lesions, the accessibility and important complications.
The Archimedes® system is an improved version of LungPoint® and combines 3D reconstruction of chest images with intraoperative radioscopy.
It uses a catheter to access through the bronchial wall the pulmonary parenchyma and navigate to the SPN.
All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections.
A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology.
The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia.
Immediate monitoring consisted in a chest x-ray 1hour after the procedure.
Patients' participation in the study will stop once they benefit from their thoracic surgery
Study Type
Interventional
Enrollment (Actual)
3
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
-
-
-
Limoges, France, 87042
- Chu de Limoges
-
-
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 to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients aged 18 to 75 years with a suspicious nodule of malignancy (primary lung tumor or metastasis of another solid tumor whose largest diameter is greater than or equal to 8 mm):
- Not associated with endobronchial tumor visible during inspection of tracheobronchial tree with soft bronchoscope
- Located in any part of the lung more than 10mm from the pleura
- For which surgical management (atypical resection, lobectomy, bilobectomy or pneumonectomy) is planned after presentation of the file at a multidisciplinary consultation meeting on thoracic oncology of the Investigating Hospital Center
- Patient able to understand the course of the study and giving informed consent
- Affiliate or beneficiary of a social security scheme
Exclusion Criteria:
- Threatening cardiac arrhythmias defined by a rhythm disorder dating discovered less than a month ago
- Myocardial infarction less than one month old
- Hypercapnic respiratory decompensation less than one month old
- coagulopathy
- Thrombocytopenia with platelet count <100,000 / mm3
- Antecedent (ATCD) of significant bleeding during previous bronchoscopy
- ATCD of pulmonary arterial hypertension (PAH) or suspicion of PAH defined by a measurement of systolic pulmonary arterial pressure greater than 50 mmHg on echocardiography (this examination is not systematic but the suspicion of PAH on the thoracic CT scan leads to other cardiac echocardiographic examinations or right heart catheterization in case of inconclusive ultrasound)
- ATCD of pneumonectomy
- Giant bubble> 5cm located near the nodule or the tunneling path
- Inability to stop anticoagulant or antiplatelet therapy before the procedure (taking acetylsalicylic acid at any dose is allowed)
- Pregnant or lactating woman
- ATCD for thoracic radiotherapy on the nodule side
- Patient under tutorship or curatorship
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: Archimedes procedure
All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections.
A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology.
The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia.
Immediate monitoring consisted in a chest x-ray 1hour after the procedure.
|
All patients will initially have a scanner necessary for planning by the Archimedes system of the tunneling path.
each patient will then undergo a general anesthesia as for any bronchoscopy.
Then start the Archimedes procedure itself to reach the SPN
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of diagnostics obtained with the Archimedes system
Time Frame: Month 1
|
It will be the biopsy yield defined as the number of patients in whom the results of nodule biopsies performed with the Archimedes® system are consistent with the surgical specimen.
|
Month 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Scheduling time of the procedure
Time Frame: Day 21
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Procedure scheduling time defined by the number of minutes elapsed between recording the patient's chest scanner on the console and when the tunneling path was examined, selected, and exported
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Day 21
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Access time to the nodule
Time Frame: Day 21
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Nodule access time defined as the number of minutes elapsed between the start of navigation and the placement of the sheath within the SPN
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Day 21
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Fluoroscopy time
Time Frame: Day 21
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Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation
|
Day 21
|
Patient registration time
Time Frame: Day 21
|
Patient recording time defined as the number of minutes required to correlate the patient's position through fluoroscopy with the navigation aid system.
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Day 21
|
morbi-mortality
Time Frame: Month 1
|
number of hemoptysis and pneumothorax
|
Month 1
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas EGENOD, MD, University Hospital, Limoges
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)
January 21, 2021
Primary Completion (Actual)
July 1, 2021
Study Completion (Actual)
July 1, 2021
Study Registration Dates
First Submitted
October 22, 2019
First Submitted That Met QC Criteria
October 23, 2019
First Posted (Actual)
October 28, 2019
Study Record Updates
Last Update Posted (Actual)
September 14, 2021
Last Update Submitted That Met QC Criteria
September 7, 2021
Last Verified
September 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 87RI18_0030 (SATAN)
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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