NCT04722432

Brief Summary

A novel OTS detachable probe system carried outside and along the flexible bronchoscope has been developed. Using this novel system, the operator can deploy the probe in the target bronchus and lesion and completely detach the scope from the probe.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
6

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

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 16, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 25, 2021

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2023

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

2.9 years

First QC Date

October 16, 2020

Last Update Submit

February 1, 2024

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

  • accuracy of the deployment method

    will be measured by bidimensional fluoroscopy images (antero-posterior and latero-lateral). The deployment will be considered successful if the tip of the probe is positioned at a distance less than 5 mm in both axes from the target model and stay stable in place over 5 minutes of ventilation.

    Time of procedure

Study Arms (1)

Système de cathéter détachable dehors du scope (DDS)

EXPERIMENTAL
Device: Outside the Scope (OTS), Detachable Catheter System

Interventions

Outside the Scope (OTS), Detachable Catheter SystemDEVICE

Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study

Système de cathéter détachable dehors du scope (DDS)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who follow surgery for the removal of diseased lungs before being submitted to a bilateral lung transplant.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHUM

Montreal, Quebec, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

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

Study Record Dates

First Submitted

October 16, 2020

First Posted

January 25, 2021

Study Start

October 16, 2020

Primary Completion

September 21, 2023

Study Completion

September 21, 2023

Last Updated

February 2, 2024

Record last verified: 2024-02

Locations

CA(1)