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

Not Applicable

Completed

• Conditions: Lung Cancer
• Interventions: Device: Outside the Scope (OTS), Detachable Catheter System

• Registration Number: NCT04722432
• Lead Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

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.

Detailed Description

Lung ablative therapies have growing interest in the treatment of early-stage primary lung cancer in surgical high-risk patients and as part of multimodal treatment in patients with large lesions or metastatic malignant disease in the lungs. Endobronchial ablative strategies allow deliver y of these therapies through a natural orifice and minimally invasive approach, potentially improving safety and reducing related morbidity. Application and deployment of this system allows the operator to have constant control of the airway, preventing life-threatening hemoptysis and other complications. We hypothesize that this novel detachable OTS system can be successfully deployed in the peripheral parenchymal target with potential clinical applications in the near future.

Study Timeline

• Study Start: 2020-10-16
• Study First Submitted: 2020-10-16
• Study First Submitted QC: 2021-01-22
• Study First Posted: 2021-01-25
• Primary Completion: 2023-09-21
• Study Completion: 2023-09-21
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-01
• Last Update Posted: 2024-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Système de cathéter détachable dehors du scope (DDS)	Outside the Scope (OTS), Detachable Catheter System	-

Primary Outcome Measures

Name	Time	Method
accuracy of the deployment method	Time of procedure	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.

Trial Locations

Locations (1)

CHUM; 🇨🇦 Montréal, Quebec, Canada