BronchoscopySATANNCT04140474
Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
A study testing Archimedes procedure in people with Bronchoscopy and Lung Cancer, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
- What is being tested?
- Archimedes procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 21 Jan 2021to 1 Jul 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
- Being tested
- Archimedes procedure
- Keywords
- bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
- Medical subject headings
- Lung Neoplasms, Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Archimedes procedureDevice
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
| Study group | Role | What they receive |
|---|---|---|
| Archimedes procedure | Experimental | 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. Receives: Device: Archimedes procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Month 1
Secondary outcomes (5)
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
Measured: Day 21
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
Measured: Day 21
Fluoroscopy time
Fluoroscopy time defined by the number of minutes the patient is exposed to ionizing radiation
Measured: Day 21
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.
Measured: Day 21
morbi-mortality
number of hemoptysis and pneumothorax
Measured: Month 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start21 Jan 2021
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Why it stopped: Inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchoscopyStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas EGENOD, MD, Principal investigator, University Hospital, Limoges
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04140474
- Sponsor's protocol ID
- 87RI18_0030 (SATAN)
- Acronym
- SATAN
- Status last verified
- Sep 2021
- First submitted
- 22 Oct 2019
- Last updated
- 14 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
- ClinicalTrials.gov ID
- NCT04140474
- Acronym / sponsor ID
- SATAN / 87RI18_0030 (SATAN)
- Conditions
- Bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
- Keywords
- bronchoscopy, Lung Cancer, Solitary Pulmonary Nodule
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion difficulties
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 21 Jan 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 28 Oct 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 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Archimedes procedure | Experimental | Device: Archimedes procedureAll 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Archimedes procedureAll 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 | Device | Archimedes procedure |
Primary outcome
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.
5 secondary outcomes
Scheduling time of the procedure
Time frame: Day 21
Access time to the nodule
Time frame: Day 21
Fluoroscopy time
Time frame: Day 21
Patient registration time
Time frame: Day 21
morbi-mortality
Time frame: Month 1
Results and safety
The study was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Bronchoscopy
Not yet recruiting
5G-Enabled Remote Robotic-Assisted Bronchoscopy-Guided Cryoablation for Pulmonary Malignancies
Lung Cancer
RecruitingObservational study
Study of the Disease Process of Lymphangioleiomyomatosis
Lung Disease, Pneumothorax
Enrolling by invitationPhase 2
Effects of Bronchial Segmental Endotoxin Instillation in Humans
Acute Lung Inflammation
Active, not recruitingObservational study
A Multicenter Study in Bronchoscopy Combining Stimulated Raman Histology With Artificial Intelligence for Rapid Lung Cancer Detection - The ON-SITE Study
Lung Biopsy, Lung Cancer
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
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.
Thomas EGENOD, MD principal investigator
University Hospital, Limoges
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Archimedes procedure in people with Bronchoscopy and Lung Cancer, run by University Hospital, Limoges 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 6 inclusion and 13 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: stopped early, as of the sponsor's last update on 14 Sep 2021. 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 was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
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 diagnostics obtained with the Archimedes system (time frame: Month 1). 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 14 Sep 2021.