NCT04140474

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 28, 2019

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 21, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

September 14, 2021

Status Verified

September 1, 2021

Enrollment Period

5 months

First QC Date

October 22, 2019

Last Update Submit

September 7, 2021

Conditions

BronchoscopyLung CancerSolitary Pulmonary Nodule

Keywords

bronchoscopyLung CancerSolitary Pulmonary Nodule

Outcome Measures

Primary Outcomes (1)

  • 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.

    Month 1

Secondary Outcomes (5)

  • Scheduling time of the procedure

    Day 21

  • Access time to the nodule

    Day 21

  • Fluoroscopy time

    Day 21

  • Patient registration time

    Day 21

  • morbi-mortality

    Month 1

Study Arms (1)

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.

Device: Archimedes procedure

Interventions

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

Archimedes procedure

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Limoges

Limoges, 87042, France

Location

MeSH Terms

Conditions

Lung NeoplasmsSolitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Thomas EGENOD, MD

    University Hospital, Limoges

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 28, 2019

Study Start

January 21, 2021

Primary Completion

July 1, 2021

Study Completion

July 1, 2021

Last Updated

September 14, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)