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Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules. (SATAN)

Primary Purpose

Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Archimedes procedure
Sponsored by
University Hospital, Limoges
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bronchoscopy focused on measuring bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Limoges

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Archimedes procedure

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of diagnostics obtained with the Archimedes system
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.

Secondary Outcome Measures

Scheduling time of the procedure
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
Access time to the nodule
Nodule access time defined as the number of minutes elapsed between the start of navigation and the placement of the sheath within the SPN
Fluoroscopy time
Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation
Patient registration time
Patient recording time defined as the number of minutes required to correlate the patient's position through fluoroscopy with the navigation aid system.
morbi-mortality
number of hemoptysis and pneumothorax

Full Information

First Posted
October 22, 2019
Last Updated
September 7, 2021
Sponsor
University Hospital, Limoges
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1. Study Identification

Unique Protocol Identification Number
NCT04140474
Brief Title
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
Acronym
SATAN
Official Title
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Terminated
Why Stopped
Inclusion difficulties
Study Start Date
January 21, 2021 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
Keywords
bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Archimedes procedure
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Archimedes procedure
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of diagnostics obtained with the Archimedes system
Description
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.
Time Frame
Month 1
Secondary Outcome Measure Information:
Title
Scheduling time of the procedure
Description
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
Time Frame
Day 21
Title
Access time to the nodule
Description
Nodule access time defined as the number of minutes elapsed between the start of navigation and the placement of the sheath within the SPN
Time Frame
Day 21
Title
Fluoroscopy time
Description
Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation
Time Frame
Day 21
Title
Patient registration time
Description
Patient recording time defined as the number of minutes required to correlate the patient's position through fluoroscopy with the navigation aid system.
Time Frame
Day 21
Title
morbi-mortality
Description
number of hemoptysis and pneumothorax
Time Frame
Month 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas EGENOD, MD
Organizational Affiliation
University Hospital, Limoges
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.

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